Trial Outcomes & Findings for Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects (NCT NCT02055976)
NCT ID: NCT02055976
Last Updated: 2019-02-08
Results Overview
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Baseline, Day 85
Results posted on
2019-02-08
Participant Flow
Participant milestones
| Measure |
Atorvastatin + PF-04950615 50 mg
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 Placebo
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
24
|
26
|
22
|
25
|
25
|
24
|
23
|
|
Overall Study
COMPLETED
|
25
|
24
|
23
|
25
|
22
|
24
|
23
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Atorvastatin + PF-04950615 50 mg
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 Placebo
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Does not meet entrance criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
Baseline characteristics by cohort
| Measure |
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 18 years
|
0 Participants
8.9 • n=5 Participants
|
0 Participants
12.2 • n=7 Participants
|
0 Participants
8.6 • n=5 Participants
|
0 Participants
11.2 • n=4 Participants
|
0 Participants
10.7 • n=21 Participants
|
0 Participants
8.4 • n=10 Participants
|
0 Participants
10.6 • n=115 Participants
|
0 Participants
8.1 • n=6 Participants
|
0 Participants
11.7 • n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Customized
18-44 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=64 Participants
|
|
Age, Customized
45-64 years
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
134 Participants
n=64 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
65 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
100 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
118 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 85Population: Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=23 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
|
-5.91 percent change
Standard Deviation 14.323 • Interval -10.453 to 0.102
|
-18.56 percent change
Standard Deviation 15.968
|
-47.25 percent change
Standard Deviation 17.699
|
-62.24 percent change
Standard Deviation 16.097
|
-65.89 percent change
Standard Deviation 10.779
|
-55.65 percent change
Standard Deviation 15.748 • Interval -60.388 to -49.639
|
-68.25 percent change
Standard Deviation 18.769 • Interval -77.547 to -66.313
|
-74.00 percent change
Standard Deviation 13.848 • Interval -82.354 to -71.066
|
-1.21 percent change
Standard Deviation 14.815
|
PRIMARY outcome
Timeframe: Baseline, Day 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=25 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=24 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=23 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
|
-12.10 percent change
Standard Deviation 12.727 • Interval -10.453 to 0.102
|
-20.55 percent change
Standard Deviation 18.682
|
-44.94 percent change
Standard Deviation 19.641
|
-61.79 percent change
Standard Deviation 15.476
|
-66.98 percent change
Standard Deviation 12.396
|
-54.41 percent change
Standard Deviation 12.062 • Interval -60.388 to -49.639
|
-64.46 percent change
Standard Deviation 19.149 • Interval -77.547 to -66.313
|
-69.98 percent change
Standard Deviation 19.074 • Interval -82.354 to -71.066
|
0.39 percent change
Standard Deviation 16.246
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 106
|
127.76 mg/dL
Standard Deviation 17.973
|
104.14 mg/dL
Standard Deviation 25.496
|
84.52 mg/dL
Standard Deviation 29.679
|
57.00 mg/dL
Standard Deviation 25.719
|
57.42 mg/dL
Standard Deviation 22.654
|
45.16 mg/dL
Standard Deviation 20.874
|
32.13 mg/dL
Standard Deviation 18.059
|
37.36 mg/dL
Standard Deviation 24.849
|
155.57 mg/dL
Standard Deviation 17.010
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Baseline
|
135.90 mg/dL
Standard Deviation 24.697
|
135.36 mg/dL
Standard Deviation 24.745
|
164.22 mg/dL
Standard Deviation 25.839
|
158.00 mg/dL
Standard Deviation 20.004
|
159.90 mg/dL
Standard Deviation 19.800
|
135.36 mg/dL
Standard Deviation 23.652
|
123.85 mg/dL
Standard Deviation 20.585
|
129.19 mg/dL
Standard Deviation 17.769
|
155.22 mg/dL
Standard Deviation 23.096
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 5
|
130.35 mg/dL
Standard Deviation 22.280
|
111.50 mg/dL
Standard Deviation 23.118
|
128.68 mg/dL
Standard Deviation 30.905
|
120.20 mg/dL
Standard Deviation 21.352
|
114.63 mg/dL
Standard Deviation 30.177
|
86.72 mg/dL
Standard Deviation 24.917
|
71.83 mg/dL
Standard Deviation 26.020
|
76.04 mg/dL
Standard Deviation 17.111
|
165.09 mg/dL
Standard Deviation 22.880
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 15
|
132.50 mg/dL
Standard Deviation 19.449
|
102.64 mg/dL
Standard Deviation 19.458
|
113.28 mg/dL
Standard Deviation 36.371
|
80.44 mg/dL
Standard Deviation 25.366
|
77.08 mg/dL
Standard Deviation 25.943
|
73.76 mg/dL
Standard Deviation 18.807
|
51.96 mg/dL
Standard Deviation 23.921
|
39.00 mg/dL
Standard Deviation 16.395
|
165.39 mg/dL
Standard Deviation 21.148
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 22
|
133.27 mg/dL
Standard Deviation 19.359
|
101.68 mg/dL
Standard Deviation 21.825
|
90.32 mg/dL
Standard Deviation 34.956
|
67.29 mg/dL
Standard Deviation 26.527
|
67.71 mg/dL
Standard Deviation 32.399
|
49.08 mg/dL
Standard Deviation 19.577
|
37.58 mg/dL
Standard Deviation 20.011
|
31.00 mg/dL
Standard Deviation 11.176
|
166.04 mg/dL
Standard Deviation 15.741
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 29
|
129.60 mg/dL
Standard Deviation 23.381
|
107.50 mg/dL
Standard Deviation 23.299
|
93.36 mg/dL
Standard Deviation 36.718
|
65.20 mg/dL
Standard Deviation 17.970
|
63.58 mg/dL
Standard Deviation 23.404
|
61.56 mg/dL
Standard Deviation 24.316
|
48.29 mg/dL
Standard Deviation 21.814
|
34.26 mg/dL
Standard Deviation 13.965
|
168.14 mg/dL
Standard Deviation 24.032
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 36
|
128.50 mg/dL
Standard Deviation 23.930
|
103.05 mg/dL
Standard Deviation 26.462
|
80.64 mg/dL
Standard Deviation 34.744
|
60.67 mg/dL
Standard Deviation 19.257
|
60.75 mg/dL
Standard Deviation 27.619
|
44.40 mg/dL
Standard Deviation 19.967
|
35.13 mg/dL
Standard Deviation 17.306
|
29.52 mg/dL
Standard Deviation 11.233
|
154.00 mg/dL
Standard Deviation 22.815
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 57
|
125.27 mg/dL
Standard Deviation 20.330
|
99.27 mg/dL
Standard Deviation 26.705
|
81.32 mg/dL
Standard Deviation 33.628
|
63.54 mg/dL
Standard Deviation 25.072
|
55.75 mg/dL
Standard Deviation 26.272
|
56.88 mg/dL
Standard Deviation 18.306
|
37.21 mg/dL
Standard Deviation 18.352
|
29.61 mg/dL
Standard Deviation 11.053
|
152.91 mg/dL
Standard Deviation 15.395
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 99
|
125.80 mg/dL
Standard Deviation 15.992
|
106.14 mg/dL
Standard Deviation 31.001
|
93.80 mg/dL
Standard Deviation 29.672
|
61.67 mg/dL
Standard Deviation 31.175
|
54.25 mg/dL
Standard Deviation 20.339
|
66.48 mg/dL
Standard Deviation 23.208
|
41.96 mg/dL
Standard Deviation 18.995
|
38.09 mg/dL
Standard Deviation 25.183
|
163.70 mg/dL
Standard Deviation 17.778
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 127
|
131.92 mg/dL
Standard Deviation 21.922
|
132.73 mg/dL
Standard Deviation 29.660
|
137.00 mg/dL
Standard Deviation 36.894
|
87.22 mg/dL
Standard Deviation 42.031
|
78.96 mg/dL
Standard Deviation 25.696
|
108.16 mg/dL
Standard Deviation 21.893
|
86.71 mg/dL
Standard Deviation 27.414
|
61.87 mg/dL
Standard Deviation 33.267
|
161.17 mg/dL
Standard Deviation 24.383
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 155
|
133.92 mg/dL
Standard Deviation 23.240
|
139.45 mg/dL
Standard Deviation 35.880
|
165.17 mg/dL
Standard Deviation 31.251
|
140.78 mg/dL
Standard Deviation 29.645
|
119.54 mg/dL
Standard Deviation 32.896
|
126.52 mg/dL
Standard Deviation 23.631
|
113.75 mg/dL
Standard Deviation 19.236
|
110.57 mg/dL
Standard Deviation 26.678
|
158.17 mg/dL
Standard Deviation 15.135
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 8
|
132.08 mg/dL
Standard Deviation 21.244
|
105.86 mg/dL
Standard Deviation 21.070
|
118.20 mg/dL
Standard Deviation 33.823
|
102.63 mg/dL
Standard Deviation 26.577
|
96.50 mg/dL
Standard Deviation 36.130
|
70.36 mg/dL
Standard Deviation 18.932
|
55.38 mg/dL
Standard Deviation 28.309
|
57.71 mg/dL
Standard Deviation 16.433
|
167.22 mg/dL
Standard Deviation 23.537
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 43
|
126.23 mg/dL
Standard Deviation 14.356
|
104.95 mg/dL
Standard Deviation 23.941
|
87.76 mg/dL
Standard Deviation 36.555
|
64.84 mg/dL
Standard Deviation 19.882
|
61.83 mg/dL
Standard Deviation 29.732
|
58.24 mg/dL
Standard Deviation 21.357
|
39.63 mg/dL
Standard Deviation 20.342
|
31.83 mg/dL
Standard Deviation 11.750
|
167.30 mg/dL
Standard Deviation 21.850
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 50
|
127.92 mg/dL
Standard Deviation 20.392
|
106.23 mg/dL
Standard Deviation 21.728
|
76.96 mg/dL
Standard Deviation 32.194
|
57.91 mg/dL
Standard Deviation 20.889
|
59.29 mg/dL
Standard Deviation 28.406
|
39.76 mg/dL
Standard Deviation 16.042
|
32.33 mg/dL
Standard Deviation 16.578
|
29.96 mg/dL
Standard Deviation 11.400
|
158.83 mg/dL
Standard Deviation 17.031
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 71
|
130.31 mg/dL
Standard Deviation 21.031
|
109.18 mg/dL
Standard Deviation 26.412
|
90.96 mg/dL
Standard Deviation 34.188
|
60.63 mg/dL
Standard Deviation 24.315
|
57.33 mg/dL
Standard Deviation 25.237
|
61.50 mg/dL
Standard Deviation 22.683
|
36.29 mg/dL
Standard Deviation 18.196
|
33.13 mg/dL
Standard Deviation 13.384
|
156.70 mg/dL
Standard Deviation 25.663
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 85
|
126.38 mg/dL
Standard Deviation 21.478
|
110.64 mg/dL
Standard Deviation 33.530
|
86.64 mg/dL
Standard Deviation 30.447
|
59.83 mg/dL
Standard Deviation 27.495
|
54.71 mg/dL
Standard Deviation 18.388
|
58.96 mg/dL
Standard Deviation 19.650
|
38.00 mg/dL
Standard Deviation 19.077
|
33.91 mg/dL
Standard Deviation 19.400
|
151.30 mg/dL
Standard Deviation 21.137
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 113
|
118.88 mg/dL
Standard Deviation 22.883
|
107.32 mg/dL
Standard Deviation 30.459
|
89.44 mg/dL
Standard Deviation 29.798
|
61.48 mg/dL
Standard Deviation 28.511
|
53.39 mg/dL
Standard Deviation 20.954
|
62.17 mg/dL
Standard Deviation 20.417
|
42.88 mg/dL
Standard Deviation 19.427
|
38.48 mg/dL
Standard Deviation 24.346
|
153.30 mg/dL
Standard Deviation 16.255
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 141
|
129.32 mg/dL
Standard Deviation 20.860
|
139.14 mg/dL
Standard Deviation 38.095
|
160.80 mg/dL
Standard Deviation 37.487
|
130.22 mg/dL
Standard Deviation 40.707
|
103.08 mg/dL
Standard Deviation 34.759
|
126.13 mg/dL
Standard Deviation 26.555
|
111.38 mg/dL
Standard Deviation 24.588
|
95.30 mg/dL
Standard Deviation 37.497
|
163.52 mg/dL
Standard Deviation 22.224
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
Day 169
|
129.28 mg/dL
Standard Deviation 24.576
|
140.91 mg/dL
Standard Deviation 39.309
|
168.50 mg/dL
Standard Deviation 28.657
|
154.52 mg/dL
Standard Deviation 21.715
|
137.13 mg/dL
Standard Deviation 32.817
|
131.28 mg/dL
Standard Deviation 25.988
|
123.42 mg/dL
Standard Deviation 25.782
|
124.04 mg/dL
Standard Deviation 24.453
|
168.55 mg/dL
Standard Deviation 19.767
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
Change at Day 85
|
-9.52 mg/dL
Standard Deviation 21.041
|
-24.73 mg/dL
Standard Deviation 23.125
|
-77.58 mg/dL
Standard Deviation 29.943
|
-99.28 mg/dL
Standard Deviation 32.550
|
-105.19 mg/dL
Standard Deviation 19.833
|
-76.40 mg/dL
Standard Deviation 26.447
|
-85.85 mg/dL
Standard Deviation 28.977
|
-95.11 mg/dL
Standard Deviation 21.145
|
-3.91 mg/dL
Standard Deviation 23.632
|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
Change at Day 113
|
-17.48 mg/dL
Standard Deviation 20.767
|
-28.05 mg/dL
Standard Deviation 23.663
|
-74.78 mg/dL
Standard Deviation 34.970
|
-97.63 mg/dL
Standard Deviation 25.545
|
-107.57 mg/dL
Standard Deviation 21.765
|
-73.33 mg/dL
Standard Deviation 18.047
|
-80.98 mg/dL
Standard Deviation 28.902
|
-90.54 mg/dL
Standard Deviation 28.496
|
-1.91 mg/dL
Standard Deviation 20.147
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Cholesterol (TC)
Day 99
|
216.28 mg/dL
Standard Deviation 19.250
|
194.05 mg/dL
Standard Deviation 33.230
|
178.36 mg/dL
Standard Deviation 33.103
|
149.83 mg/dL
Standard Deviation 33.780
|
139.13 mg/dL
Standard Deviation 32.510
|
151.24 mg/dL
Standard Deviation 31.139
|
128.58 mg/dL
Standard Deviation 28.864
|
122.36 mg/dL
Standard Deviation 36.702
|
249.83 mg/dL
Standard Deviation 19.277
|
|
Total Cholesterol (TC)
Day 155
|
221.28 mg/dL
Standard Deviation 24.455
|
228.86 mg/dL
Standard Deviation 37.640
|
250.00 mg/dL
Standard Deviation 34.453
|
227.83 mg/dL
Standard Deviation 31.438
|
208.25 mg/dL
Standard Deviation 33.069
|
208.32 mg/dL
Standard Deviation 28.912
|
203.83 mg/dL
Standard Deviation 24.533
|
195.26 mg/dL
Standard Deviation 31.865
|
246.35 mg/dL
Standard Deviation 15.171
|
|
Total Cholesterol (TC)
Day 169
|
221.00 mg/dL
Standard Deviation 26.091
|
234.95 mg/dL
Standard Deviation 43.216
|
254.17 mg/dL
Standard Deviation 32.859
|
245.57 mg/dL
Standard Deviation 34.103
|
227.65 mg/dL
Standard Deviation 39.088
|
212.96 mg/dL
Standard Deviation 29.508
|
212.79 mg/dL
Standard Deviation 25.267
|
211.00 mg/dL
Standard Deviation 31.348
|
258.64 mg/dL
Standard Deviation 20.537
|
|
Total Cholesterol (TC)
Baseline
|
222.44 mg/dL
Standard Deviation 31.317
|
222.84 mg/dL
Standard Deviation 25.395
|
245.94 mg/dL
Standard Deviation 30.425
|
243.26 mg/dL
Standard Deviation 21.967
|
244.19 mg/dL
Standard Deviation 29.987
|
214.16 mg/dL
Standard Deviation 30.658
|
210.29 mg/dL
Standard Deviation 21.594
|
211.71 mg/dL
Standard Deviation 23.065
|
242.04 mg/dL
Standard Deviation 22.956
|
|
Total Cholesterol (TC)
Day 5
|
219.42 mg/dL
Standard Deviation 24.861
|
197.77 mg/dL
Standard Deviation 25.487
|
211.56 mg/dL
Standard Deviation 37.176
|
203.56 mg/dL
Standard Deviation 28.777
|
199.58 mg/dL
Standard Deviation 41.618
|
169.20 mg/dL
Standard Deviation 28.586
|
154.83 mg/dL
Standard Deviation 30.045
|
156.91 mg/dL
Standard Deviation 22.240
|
249.09 mg/dL
Standard Deviation 24.156
|
|
Total Cholesterol (TC)
Day 8
|
222.68 mg/dL
Standard Deviation 28.253
|
190.19 mg/dL
Standard Deviation 20.856
|
202.44 mg/dL
Standard Deviation 37.095
|
184.58 mg/dL
Standard Deviation 30.935
|
186.73 mg/dL
Standard Deviation 44.905
|
149.72 mg/dL
Standard Deviation 24.979
|
137.71 mg/dL
Standard Deviation 31.992
|
136.50 mg/dL
Standard Deviation 21.364
|
254.26 mg/dL
Standard Deviation 22.481
|
|
Total Cholesterol (TC)
Day 15
|
221.69 mg/dL
Standard Deviation 23.988
|
190.50 mg/dL
Standard Deviation 20.964
|
198.64 mg/dL
Standard Deviation 39.145
|
165.48 mg/dL
Standard Deviation 30.456
|
165.71 mg/dL
Standard Deviation 37.735
|
154.20 mg/dL
Standard Deviation 26.011
|
137.83 mg/dL
Standard Deviation 27.241
|
120.75 mg/dL
Standard Deviation 25.589
|
251.91 mg/dL
Standard Deviation 24.830
|
|
Total Cholesterol (TC)
Day 22
|
218.12 mg/dL
Standard Deviation 24.006
|
190.64 mg/dL
Standard Deviation 23.768
|
176.28 mg/dL
Standard Deviation 36.510
|
152.63 mg/dL
Standard Deviation 29.854
|
153.67 mg/dL
Standard Deviation 43.213
|
129.28 mg/dL
Standard Deviation 22.856
|
119.00 mg/dL
Standard Deviation 26.462
|
112.78 mg/dL
Standard Deviation 19.247
|
253.57 mg/dL
Standard Deviation 15.716
|
|
Total Cholesterol (TC)
Day 29
|
217.12 mg/dL
Standard Deviation 24.280
|
192.41 mg/dL
Standard Deviation 31.173
|
176.36 mg/dL
Standard Deviation 41.260
|
153.20 mg/dL
Standard Deviation 25.762
|
150.42 mg/dL
Standard Deviation 34.557
|
141.04 mg/dL
Standard Deviation 27.355
|
133.54 mg/dL
Standard Deviation 25.507
|
114.91 mg/dL
Standard Deviation 24.487
|
256.73 mg/dL
Standard Deviation 22.391
|
|
Total Cholesterol (TC)
Day 36
|
217.08 mg/dL
Standard Deviation 26.204
|
187.55 mg/dL
Standard Deviation 30.803
|
163.48 mg/dL
Standard Deviation 39.528
|
147.08 mg/dL
Standard Deviation 25.568
|
144.63 mg/dL
Standard Deviation 40.577
|
124.12 mg/dL
Standard Deviation 22.380
|
113.88 mg/dL
Standard Deviation 25.000
|
107.35 mg/dL
Standard Deviation 19.590
|
244.65 mg/dL
Standard Deviation 24.356
|
|
Total Cholesterol (TC)
Day 43
|
214.62 mg/dL
Standard Deviation 19.179
|
190.86 mg/dL
Standard Deviation 28.734
|
171.96 mg/dL
Standard Deviation 40.287
|
151.80 mg/dL
Standard Deviation 23.638
|
147.25 mg/dL
Standard Deviation 41.429
|
139.40 mg/dL
Standard Deviation 23.944
|
128.83 mg/dL
Standard Deviation 30.724
|
113.75 mg/dL
Standard Deviation 23.167
|
254.04 mg/dL
Standard Deviation 19.793
|
|
Total Cholesterol (TC)
Day 50
|
215.42 mg/dL
Standard Deviation 23.262
|
189.18 mg/dL
Standard Deviation 24.209
|
161.00 mg/dL
Standard Deviation 37.653
|
145.22 mg/dL
Standard Deviation 24.814
|
144.17 mg/dL
Standard Deviation 40.223
|
120.04 mg/dL
Standard Deviation 20.687
|
112.63 mg/dL
Standard Deviation 23.585
|
107.74 mg/dL
Standard Deviation 22.471
|
246.09 mg/dL
Standard Deviation 17.776
|
|
Total Cholesterol (TC)
Day 57
|
208.04 mg/dL
Standard Deviation 23.282
|
184.14 mg/dL
Standard Deviation 31.148
|
158.96 mg/dL
Standard Deviation 39.046
|
148.00 mg/dL
Standard Deviation 30.107
|
135.83 mg/dL
Standard Deviation 39.794
|
134.16 mg/dL
Standard Deviation 25.826
|
116.96 mg/dL
Standard Deviation 24.489
|
104.61 mg/dL
Standard Deviation 20.045
|
236.78 mg/dL
Standard Deviation 16.105
|
|
Total Cholesterol (TC)
Day 71
|
218.38 mg/dL
Standard Deviation 23.474
|
192.91 mg/dL
Standard Deviation 31.288
|
174.64 mg/dL
Standard Deviation 37.758
|
146.17 mg/dL
Standard Deviation 29.736
|
142.42 mg/dL
Standard Deviation 37.326
|
142.13 mg/dL
Standard Deviation 29.489
|
121.04 mg/dL
Standard Deviation 28.608
|
113.48 mg/dL
Standard Deviation 25.056
|
243.74 mg/dL
Standard Deviation 24.849
|
|
Total Cholesterol (TC)
Day 85
|
208.88 mg/dL
Standard Deviation 24.747
|
198.82 mg/dL
Standard Deviation 36.000
|
165.44 mg/dL
Standard Deviation 32.651
|
141.09 mg/dL
Standard Deviation 31.318
|
134.17 mg/dL
Standard Deviation 30.972
|
135.52 mg/dL
Standard Deviation 25.161
|
119.58 mg/dL
Standard Deviation 24.959
|
109.57 mg/dL
Standard Deviation 27.611
|
231.52 mg/dL
Standard Deviation 22.701
|
|
Total Cholesterol (TC)
Day 106
|
212.36 mg/dL
Standard Deviation 22.002
|
190.27 mg/dL
Standard Deviation 28.352
|
167.84 mg/dL
Standard Deviation 32.859
|
142.26 mg/dL
Standard Deviation 32.265
|
139.92 mg/dL
Standard Deviation 35.003
|
126.40 mg/dL
Standard Deviation 29.017
|
114.75 mg/dL
Standard Deviation 26.967
|
118.55 mg/dL
Standard Deviation 29.987
|
241.65 mg/dL
Standard Deviation 18.982
|
|
Total Cholesterol (TC)
Day 113
|
201.64 mg/dL
Standard Deviation 26.967
|
191.73 mg/dL
Standard Deviation 34.189
|
169.72 mg/dL
Standard Deviation 31.052
|
146.00 mg/dL
Standard Deviation 33.889
|
134.17 mg/dL
Standard Deviation 31.400
|
140.63 mg/dL
Standard Deviation 26.650
|
124.58 mg/dL
Standard Deviation 27.910
|
115.17 mg/dL
Standard Deviation 30.293
|
236.83 mg/dL
Standard Deviation 16.808
|
|
Total Cholesterol (TC)
Day 127
|
219.32 mg/dL
Standard Deviation 26.684
|
221.18 mg/dL
Standard Deviation 32.444
|
223.16 mg/dL
Standard Deviation 39.032
|
176.74 mg/dL
Standard Deviation 46.917
|
166.63 mg/dL
Standard Deviation 34.144
|
193.96 mg/dL
Standard Deviation 26.253
|
176.88 mg/dL
Standard Deviation 32.328
|
147.87 mg/dL
Standard Deviation 37.486
|
249.78 mg/dL
Standard Deviation 25.598
|
|
Total Cholesterol (TC)
Day 141
|
216.48 mg/dL
Standard Deviation 22.450
|
229.50 mg/dL
Standard Deviation 38.480
|
247.36 mg/dL
Standard Deviation 40.025
|
217.43 mg/dL
Standard Deviation 43.351
|
192.96 mg/dL
Standard Deviation 37.406
|
209.75 mg/dL
Standard Deviation 32.446
|
202.71 mg/dL
Standard Deviation 26.989
|
184.09 mg/dL
Standard Deviation 38.141
|
253.48 mg/dL
Standard Deviation 21.494
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Change at Day 85
|
-13.56 mg/dL
Standard Deviation 22.346
|
-24.02 mg/dL
Standard Deviation 26.166
|
-80.50 mg/dL
Standard Deviation 31.851
|
-102.80 mg/dL
Standard Deviation 34.603
|
-110.02 mg/dL
Standard Deviation 24.119
|
-78.64 mg/dL
Standard Deviation 28.525
|
-90.71 mg/dL
Standard Deviation 31.705
|
-101.43 mg/dL
Standard Deviation 25.436
|
-10.52 mg/dL
Standard Deviation 26.111
|
|
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Change at Day 113
|
-21.68 mg/dL
Standard Deviation 23.686
|
-31.11 mg/dL
Standard Deviation 24.992
|
-76.22 mg/dL
Standard Deviation 36.301
|
-97.89 mg/dL
Standard Deviation 29.274
|
-111.96 mg/dL
Standard Deviation 24.871
|
-73.44 mg/dL
Standard Deviation 21.242
|
-85.71 mg/dL
Standard Deviation 30.263
|
-95.83 mg/dL
Standard Deviation 27.765
|
-5.22 mg/dL
Standard Deviation 20.333
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Change at Day 113
|
-9.18 percent change
Standard Deviation 9.204
|
-14.02 percent change
Standard Deviation 10.900
|
-30.50 percent change
Standard Deviation 13.212
|
-40.27 percent change
Standard Deviation 11.798
|
-45.71 percent change
Standard Deviation 9.786
|
-34.28 percent change
Standard Deviation 8.799
|
-40.55 percent change
Standard Deviation 13.471
|
-45.58 percent change
Standard Deviation 12.422
|
-1.62 percent change
Standard Deviation 8.941
|
|
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Change at Day 85
|
-5.47 percent change
Standard Deviation 9.038
|
-10.85 percent change
Standard Deviation 11.295
|
-32.56 percent change
Standard Deviation 12.011
|
-41.98 percent change
Standard Deviation 12.224
|
-45.28 percent change
Standard Deviation 9.539
|
-36.26 percent change
Standard Deviation 11.313
|
-42.64 percent change
Standard Deviation 13.310
|
-48.22 percent change
Standard Deviation 11.066
|
-3.82 percent change
Standard Deviation 10.484
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apolipoprotein B (ApoB)
Day 155
|
96.00 mg/dL
Standard Deviation 11.832
|
101.23 mg/dL
Standard Deviation 18.619
|
111.39 mg/dL
Standard Deviation 17.758
|
98.26 mg/dL
Standard Deviation 19.262
|
86.04 mg/dL
Standard Deviation 23.451
|
90.16 mg/dL
Standard Deviation 14.291
|
89.00 mg/dL
Standard Deviation 15.836
|
81.87 mg/dL
Standard Deviation 16.652
|
108.43 mg/dL
Standard Deviation 10.422
|
|
Apolipoprotein B (ApoB)
Day 15
|
96.65 mg/dL
Standard Deviation 13.069
|
79.36 mg/dL
Standard Deviation 9.639
|
82.24 mg/dL
Standard Deviation 21.127
|
62.28 mg/dL
Standard Deviation 16.403
|
58.08 mg/dL
Standard Deviation 12.265
|
60.20 mg/dL
Standard Deviation 15.658
|
49.38 mg/dL
Standard Deviation 15.528
|
36.50 mg/dL
Standard Deviation 8.703
|
107.39 mg/dL
Standard Deviation 12.052
|
|
Apolipoprotein B (ApoB)
Day 22
|
96.35 mg/dL
Standard Deviation 10.954
|
79.77 mg/dL
Standard Deviation 12.976
|
68.76 mg/dL
Standard Deviation 20.949
|
53.46 mg/dL
Standard Deviation 14.700
|
50.54 mg/dL
Standard Deviation 15.300
|
44.28 mg/dL
Standard Deviation 13.227
|
36.83 mg/dL
Standard Deviation 12.923
|
31.09 mg/dL
Standard Deviation 5.938
|
108.35 mg/dL
Standard Deviation 10.530
|
|
Apolipoprotein B (ApoB)
Day 43
|
94.31 mg/dL
Standard Deviation 9.216
|
82.68 mg/dL
Standard Deviation 12.797
|
67.24 mg/dL
Standard Deviation 19.959
|
53.60 mg/dL
Standard Deviation 14.283
|
48.50 mg/dL
Standard Deviation 14.301
|
51.36 mg/dL
Standard Deviation 14.494
|
42.50 mg/dL
Standard Deviation 17.942
|
31.96 mg/dL
Standard Deviation 7.538
|
110.39 mg/dL
Standard Deviation 11.645
|
|
Apolipoprotein B (ApoB)
Day 50
|
95.69 mg/dL
Standard Deviation 12.802
|
82.86 mg/dL
Standard Deviation 12.822
|
62.28 mg/dL
Standard Deviation 19.932
|
49.43 mg/dL
Standard Deviation 11.469
|
47.58 mg/dL
Standard Deviation 14.443
|
38.48 mg/dL
Standard Deviation 10.759
|
34.08 mg/dL
Standard Deviation 12.728
|
30.52 mg/dL
Standard Deviation 6.660
|
107.22 mg/dL
Standard Deviation 11.062
|
|
Apolipoprotein B (ApoB)
Day 99
|
95.08 mg/dL
Standard Deviation 12.165
|
84.05 mg/dL
Standard Deviation 16.247
|
72.56 mg/dL
Standard Deviation 18.063
|
53.63 mg/dL
Standard Deviation 17.272
|
45.88 mg/dL
Standard Deviation 11.211
|
57.36 mg/dL
Standard Deviation 17.291
|
44.29 mg/dL
Standard Deviation 17.853
|
37.55 mg/dL
Standard Deviation 18.913
|
110.91 mg/dL
Standard Deviation 11.049
|
|
Apolipoprotein B (ApoB)
Day 106
|
94.36 mg/dL
Standard Deviation 12.192
|
83.32 mg/dL
Standard Deviation 14.965
|
66.72 mg/dL
Standard Deviation 17.111
|
48.87 mg/dL
Standard Deviation 13.168
|
47.00 mg/dL
Standard Deviation 12.332
|
42.12 mg/dL
Standard Deviation 13.233
|
34.71 mg/dL
Standard Deviation 15.029
|
35.55 mg/dL
Standard Deviation 15.987
|
107.48 mg/dL
Standard Deviation 10.117
|
|
Apolipoprotein B (ApoB)
Day 113
|
88.40 mg/dL
Standard Deviation 13.438
|
82.77 mg/dL
Standard Deviation 15.593
|
69.08 mg/dL
Standard Deviation 17.007
|
52.52 mg/dL
Standard Deviation 15.774
|
45.87 mg/dL
Standard Deviation 11.530
|
53.50 mg/dL
Standard Deviation 13.593
|
42.83 mg/dL
Standard Deviation 16.612
|
36.48 mg/dL
Standard Deviation 15.111
|
105.61 mg/dL
Standard Deviation 9.940
|
|
Apolipoprotein B (ApoB)
Day 141
|
95.08 mg/dL
Standard Deviation 12.024
|
100.45 mg/dL
Standard Deviation 19.043
|
108.96 mg/dL
Standard Deviation 21.279
|
92.70 mg/dL
Standard Deviation 27.420
|
77.67 mg/dL
Standard Deviation 25.466
|
89.50 mg/dL
Standard Deviation 14.611
|
87.71 mg/dL
Standard Deviation 18.112
|
74.87 mg/dL
Standard Deviation 25.118
|
110.09 mg/dL
Standard Deviation 12.109
|
|
Apolipoprotein B (ApoB)
Day 169
|
96.88 mg/dL
Standard Deviation 13.532
|
103.09 mg/dL
Standard Deviation 20.718
|
112.46 mg/dL
Standard Deviation 16.005
|
105.91 mg/dL
Standard Deviation 17.661
|
95.74 mg/dL
Standard Deviation 21.764
|
93.36 mg/dL
Standard Deviation 16.176
|
93.63 mg/dL
Standard Deviation 14.455
|
91.57 mg/dL
Standard Deviation 15.147
|
111.41 mg/dL
Standard Deviation 9.879
|
|
Apolipoprotein B (ApoB)
Day 29
|
96.00 mg/dL
Standard Deviation 11.800
|
80.73 mg/dL
Standard Deviation 12.691
|
69.32 mg/dL
Standard Deviation 20.613
|
54.20 mg/dL
Standard Deviation 12.285
|
50.25 mg/dL
Standard Deviation 11.752
|
52.08 mg/dL
Standard Deviation 16.595
|
46.42 mg/dL
Standard Deviation 16.264
|
32.83 mg/dL
Standard Deviation 8.611
|
107.23 mg/dL
Standard Deviation 12.134
|
|
Apolipoprotein B (ApoB)
Day 36
|
96.27 mg/dL
Standard Deviation 14.717
|
80.18 mg/dL
Standard Deviation 13.828
|
62.40 mg/dL
Standard Deviation 19.885
|
49.25 mg/dL
Standard Deviation 8.115
|
46.92 mg/dL
Standard Deviation 14.191
|
41.04 mg/dL
Standard Deviation 11.998
|
35.50 mg/dL
Standard Deviation 13.603
|
29.43 mg/dL
Standard Deviation 6.036
|
103.74 mg/dL
Standard Deviation 13.363
|
|
Apolipoprotein B (ApoB)
Baseline
|
95.65 mg/dL
Standard Deviation 13.229
|
96.70 mg/dL
Standard Deviation 13.382
|
106.54 mg/dL
Standard Deviation 15.800
|
104.02 mg/dL
Standard Deviation 14.652
|
101.88 mg/dL
Standard Deviation 11.494
|
92.76 mg/dL
Standard Deviation 14.383
|
92.54 mg/dL
Standard Deviation 12.362
|
90.40 mg/dL
Standard Deviation 12.732
|
103.13 mg/dL
Standard Deviation 13.608
|
|
Apolipoprotein B (ApoB)
Day 5
|
94.62 mg/dL
Standard Deviation 12.847
|
84.68 mg/dL
Standard Deviation 13.570
|
88.40 mg/dL
Standard Deviation 18.777
|
82.88 mg/dL
Standard Deviation 13.179
|
78.00 mg/dL
Standard Deviation 14.025
|
67.72 mg/dL
Standard Deviation 15.175
|
59.83 mg/dL
Standard Deviation 14.269
|
60.26 mg/dL
Standard Deviation 8.853
|
104.86 mg/dL
Standard Deviation 11.902
|
|
Apolipoprotein B (ApoB)
Day 8
|
95.72 mg/dL
Standard Deviation 16.395
|
80.38 mg/dL
Standard Deviation 13.113
|
82.52 mg/dL
Standard Deviation 19.402
|
71.71 mg/dL
Standard Deviation 13.614
|
70.27 mg/dL
Standard Deviation 16.237
|
56.12 mg/dL
Standard Deviation 12.245
|
49.04 mg/dL
Standard Deviation 15.982
|
47.42 mg/dL
Standard Deviation 9.050
|
107.61 mg/dL
Standard Deviation 11.357
|
|
Apolipoprotein B (ApoB)
Day 57
|
93.81 mg/dL
Standard Deviation 12.316
|
79.68 mg/dL
Standard Deviation 15.490
|
62.00 mg/dL
Standard Deviation 19.660
|
53.25 mg/dL
Standard Deviation 17.745
|
45.79 mg/dL
Standard Deviation 12.322
|
49.44 mg/dL
Standard Deviation 14.077
|
38.29 mg/dL
Standard Deviation 16.236
|
29.48 mg/dL
Standard Deviation 6.052
|
104.13 mg/dL
Standard Deviation 9.057
|
|
Apolipoprotein B (ApoB)
Day 71
|
97.23 mg/dL
Standard Deviation 11.884
|
85.18 mg/dL
Standard Deviation 14.378
|
69.96 mg/dL
Standard Deviation 19.673
|
50.63 mg/dL
Standard Deviation 11.568
|
47.79 mg/dL
Standard Deviation 12.112
|
52.83 mg/dL
Standard Deviation 16.903
|
38.71 mg/dL
Standard Deviation 16.648
|
32.00 mg/dL
Standard Deviation 7.634
|
107.78 mg/dL
Standard Deviation 16.082
|
|
Apolipoprotein B (ApoB)
Day 85
|
93.46 mg/dL
Standard Deviation 12.666
|
86.77 mg/dL
Standard Deviation 16.934
|
68.68 mg/dL
Standard Deviation 17.409
|
49.35 mg/dL
Standard Deviation 15.183
|
45.13 mg/dL
Standard Deviation 10.678
|
51.32 mg/dL
Standard Deviation 15.258
|
39.21 mg/dL
Standard Deviation 15.291
|
33.65 mg/dL
Standard Deviation 14.717
|
102.09 mg/dL
Standard Deviation 12.387
|
|
Apolipoprotein B (ApoB)
Day 127
|
95.16 mg/dL
Standard Deviation 12.216
|
98.50 mg/dL
Standard Deviation 16.280
|
97.20 mg/dL
Standard Deviation 20.827
|
69.91 mg/dL
Standard Deviation 28.257
|
62.75 mg/dL
Standard Deviation 19.525
|
82.00 mg/dL
Standard Deviation 13.871
|
73.04 mg/dL
Standard Deviation 21.566
|
54.61 mg/dL
Standard Deviation 24.203
|
111.35 mg/dL
Standard Deviation 14.288
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Change at Day 85
|
-2.19 mg/dL
Standard Deviation 10.703
|
-9.93 mg/dL
Standard Deviation 14.350
|
-37.86 mg/dL
Standard Deviation 18.125
|
-54.33 mg/dL
Standard Deviation 21.080
|
-56.75 mg/dL
Standard Deviation 14.506
|
-41.44 mg/dL
Standard Deviation 16.385
|
-53.33 mg/dL
Standard Deviation 19.097
|
-56.43 mg/dL
Standard Deviation 17.650
|
-1.04 mg/dL
Standard Deviation 13.020
|
|
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Change at Day 113
|
-7.70 mg/dL
Standard Deviation 12.436
|
-13.93 mg/dL
Standard Deviation 12.650
|
-37.46 mg/dL
Standard Deviation 18.504
|
-51.15 mg/dL
Standard Deviation 16.855
|
-56.83 mg/dL
Standard Deviation 15.501
|
-39.56 mg/dL
Standard Deviation 12.011
|
-49.71 mg/dL
Standard Deviation 18.699
|
-53.61 mg/dL
Standard Deviation 16.526
|
2.48 mg/dL
Standard Deviation 11.107
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Change at Day 85
|
-1.77 percent change
Standard Deviation 10.567
|
-9.97 percent change
Standard Deviation 14.426
|
-35.16 percent change
Standard Deviation 15.906
|
-51.62 percent change
Standard Deviation 16.289
|
-55.31 percent change
Standard Deviation 11.060
|
-44.30 percent change
Standard Deviation 15.675
|
-57.02 percent change
Standard Deviation 17.985
|
-62.31 percent change
Standard Deviation 15.684
|
-0.13 percent change
Standard Deviation 12.144
|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Change at Day 113
|
-7.54 percent change
Standard Deviation 11.662
|
-14.17 percent change
Standard Deviation 12.713
|
-34.66 percent change
Standard Deviation 16.214
|
-49.10 percent change
Standard Deviation 14.474
|
-54.88 percent change
Standard Deviation 12.109
|
-42.64 percent change
Standard Deviation 11.864
|
-53.45 percent change
Standard Deviation 18.449
|
-59.48 percent change
Standard Deviation 15.320
|
3.43 percent change
Standard Deviation 12.038
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apolipoprotein A-I (ApoA-I)
Baseline
|
145.65 mg/dL
Standard Deviation 21.908
|
145.34 mg/dL
Standard Deviation 16.171
|
138.90 mg/dL
Standard Deviation 21.808
|
145.38 mg/dL
Standard Deviation 19.260
|
146.75 mg/dL
Standard Deviation 25.587
|
137.02 mg/dL
Standard Deviation 13.235
|
142.60 mg/dL
Standard Deviation 16.507
|
140.31 mg/dL
Standard Deviation 18.813
|
150.13 mg/dL
Standard Deviation 16.834
|
|
Apolipoprotein A-I (ApoA-I)
Day 8
|
147.00 mg/dL
Standard Deviation 21.527
|
145.57 mg/dL
Standard Deviation 16.351
|
146.76 mg/dL
Standard Deviation 25.406
|
145.79 mg/dL
Standard Deviation 19.260
|
152.45 mg/dL
Standard Deviation 28.118
|
140.44 mg/dL
Standard Deviation 14.972
|
147.46 mg/dL
Standard Deviation 16.707
|
146.88 mg/dL
Standard Deviation 19.200
|
150.48 mg/dL
Standard Deviation 16.782
|
|
Apolipoprotein A-I (ApoA-I)
Day 15
|
147.04 mg/dL
Standard Deviation 22.704
|
148.50 mg/dL
Standard Deviation 18.918
|
145.76 mg/dL
Standard Deviation 23.197
|
150.08 mg/dL
Standard Deviation 20.762
|
157.04 mg/dL
Standard Deviation 25.154
|
141.56 mg/dL
Standard Deviation 13.811
|
153.00 mg/dL
Standard Deviation 16.325
|
150.46 mg/dL
Standard Deviation 20.479
|
151.00 mg/dL
Standard Deviation 19.214
|
|
Apolipoprotein A-I (ApoA-I)
Day 29
|
144.28 mg/dL
Standard Deviation 20.633
|
146.23 mg/dL
Standard Deviation 17.221
|
146.36 mg/dL
Standard Deviation 22.503
|
150.04 mg/dL
Standard Deviation 21.763
|
155.96 mg/dL
Standard Deviation 23.143
|
144.32 mg/dL
Standard Deviation 15.118
|
155.79 mg/dL
Standard Deviation 19.598
|
151.78 mg/dL
Standard Deviation 22.913
|
154.32 mg/dL
Standard Deviation 15.304
|
|
Apolipoprotein A-I (ApoA-I)
Day 36
|
143.46 mg/dL
Standard Deviation 20.609
|
145.91 mg/dL
Standard Deviation 18.652
|
145.08 mg/dL
Standard Deviation 22.953
|
153.33 mg/dL
Standard Deviation 19.417
|
155.08 mg/dL
Standard Deviation 24.063
|
143.48 mg/dL
Standard Deviation 15.273
|
149.88 mg/dL
Standard Deviation 17.957
|
150.13 mg/dL
Standard Deviation 21.102
|
149.30 mg/dL
Standard Deviation 18.639
|
|
Apolipoprotein A-I (ApoA-I)
Day 43
|
142.42 mg/dL
Standard Deviation 21.495
|
144.64 mg/dL
Standard Deviation 16.105
|
146.00 mg/dL
Standard Deviation 21.050
|
152.32 mg/dL
Standard Deviation 21.059
|
155.75 mg/dL
Standard Deviation 32.193
|
144.52 mg/dL
Standard Deviation 12.842
|
153.88 mg/dL
Standard Deviation 18.262
|
150.33 mg/dL
Standard Deviation 22.584
|
149.04 mg/dL
Standard Deviation 16.932
|
|
Apolipoprotein A-I (ApoA-I)
Day 57
|
137.62 mg/dL
Standard Deviation 18.206
|
142.18 mg/dL
Standard Deviation 15.445
|
136.32 mg/dL
Standard Deviation 20.010
|
145.96 mg/dL
Standard Deviation 22.029
|
144.96 mg/dL
Standard Deviation 25.049
|
138.40 mg/dL
Standard Deviation 14.919
|
149.46 mg/dL
Standard Deviation 19.509
|
145.83 mg/dL
Standard Deviation 18.930
|
138.87 mg/dL
Standard Deviation 16.491
|
|
Apolipoprotein A-I (ApoA-I)
Day 106
|
143.12 mg/dL
Standard Deviation 17.822
|
144.64 mg/dL
Standard Deviation 15.413
|
142.56 mg/dL
Standard Deviation 21.143
|
149.26 mg/dL
Standard Deviation 19.909
|
150.46 mg/dL
Standard Deviation 21.444
|
145.92 mg/dL
Standard Deviation 18.773
|
154.96 mg/dL
Standard Deviation 19.282
|
150.23 mg/dL
Standard Deviation 18.341
|
141.17 mg/dL
Standard Deviation 15.497
|
|
Apolipoprotein A-I (ApoA-I)
Day 113
|
137.72 mg/dL
Standard Deviation 21.454
|
145.00 mg/dL
Standard Deviation 14.690
|
138.40 mg/dL
Standard Deviation 19.581
|
149.09 mg/dL
Standard Deviation 18.033
|
143.96 mg/dL
Standard Deviation 21.353
|
139.21 mg/dL
Standard Deviation 15.731
|
149.17 mg/dL
Standard Deviation 18.719
|
144.13 mg/dL
Standard Deviation 18.587
|
140.04 mg/dL
Standard Deviation 16.767
|
|
Apolipoprotein A-I (ApoA-I)
Day 141
|
148.52 mg/dL
Standard Deviation 23.261
|
144.45 mg/dL
Standard Deviation 16.721
|
141.36 mg/dL
Standard Deviation 20.968
|
148.74 mg/dL
Standard Deviation 17.324
|
151.29 mg/dL
Standard Deviation 22.831
|
145.46 mg/dL
Standard Deviation 19.006
|
151.21 mg/dL
Standard Deviation 18.990
|
154.17 mg/dL
Standard Deviation 22.321
|
149.13 mg/dL
Standard Deviation 19.328
|
|
Apolipoprotein A-I (ApoA-I)
Day 169
|
154.88 mg/dL
Standard Deviation 23.938
|
153.64 mg/dL
Standard Deviation 21.367
|
144.13 mg/dL
Standard Deviation 24.746
|
151.70 mg/dL
Standard Deviation 21.699
|
151.13 mg/dL
Standard Deviation 29.425
|
142.96 mg/dL
Standard Deviation 20.387
|
151.54 mg/dL
Standard Deviation 19.010
|
150.96 mg/dL
Standard Deviation 19.025
|
154.36 mg/dL
Standard Deviation 19.742
|
|
Apolipoprotein A-I (ApoA-I)
Day 5
|
146.08 mg/dL
Standard Deviation 21.505
|
144.68 mg/dL
Standard Deviation 16.193
|
142.12 mg/dL
Standard Deviation 22.260
|
145.12 mg/dL
Standard Deviation 18.485
|
149.79 mg/dL
Standard Deviation 24.285
|
140.72 mg/dL
Standard Deviation 14.644
|
146.65 mg/dL
Standard Deviation 16.773
|
144.48 mg/dL
Standard Deviation 19.943
|
150.09 mg/dL
Standard Deviation 17.989
|
|
Apolipoprotein A-I (ApoA-I)
Day 22
|
145.31 mg/dL
Standard Deviation 21.481
|
146.41 mg/dL
Standard Deviation 17.012
|
145.96 mg/dL
Standard Deviation 22.354
|
150.08 mg/dL
Standard Deviation 19.019
|
155.17 mg/dL
Standard Deviation 23.265
|
143.20 mg/dL
Standard Deviation 15.554
|
152.88 mg/dL
Standard Deviation 18.473
|
151.78 mg/dL
Standard Deviation 20.576
|
151.65 mg/dL
Standard Deviation 17.185
|
|
Apolipoprotein A-I (ApoA-I)
Day 50
|
143.46 mg/dL
Standard Deviation 20.397
|
141.95 mg/dL
Standard Deviation 15.807
|
142.84 mg/dL
Standard Deviation 21.885
|
152.52 mg/dL
Standard Deviation 19.739
|
153.92 mg/dL
Standard Deviation 25.100
|
145.80 mg/dL
Standard Deviation 15.042
|
151.25 mg/dL
Standard Deviation 19.157
|
149.13 mg/dL
Standard Deviation 19.008
|
145.70 mg/dL
Standard Deviation 14.348
|
|
Apolipoprotein A-I (ApoA-I)
Day 71
|
142.62 mg/dL
Standard Deviation 19.150
|
144.18 mg/dL
Standard Deviation 15.383
|
143.88 mg/dL
Standard Deviation 21.896
|
151.88 mg/dL
Standard Deviation 17.523
|
154.25 mg/dL
Standard Deviation 23.130
|
145.50 mg/dL
Standard Deviation 16.192
|
152.92 mg/dL
Standard Deviation 21.086
|
150.43 mg/dL
Standard Deviation 21.002
|
146.17 mg/dL
Standard Deviation 14.981
|
|
Apolipoprotein A-I (ApoA-I)
Day 85
|
136.00 mg/dL
Standard Deviation 20.229
|
144.23 mg/dL
Standard Deviation 14.498
|
132.88 mg/dL
Standard Deviation 19.303
|
145.13 mg/dL
Standard Deviation 17.168
|
146.58 mg/dL
Standard Deviation 23.006
|
138.04 mg/dL
Standard Deviation 14.968
|
148.17 mg/dL
Standard Deviation 16.818
|
144.04 mg/dL
Standard Deviation 15.933
|
136.30 mg/dL
Standard Deviation 16.753
|
|
Apolipoprotein A-I (ApoA-I)
Day 99
|
147.48 mg/dL
Standard Deviation 20.799
|
145.91 mg/dL
Standard Deviation 16.798
|
143.88 mg/dL
Standard Deviation 19.577
|
151.29 mg/dL
Standard Deviation 21.612
|
149.83 mg/dL
Standard Deviation 20.750
|
147.40 mg/dL
Standard Deviation 18.771
|
154.54 mg/dL
Standard Deviation 17.840
|
150.86 mg/dL
Standard Deviation 21.108
|
144.65 mg/dL
Standard Deviation 19.812
|
|
Apolipoprotein A-I (ApoA-I)
Day 127
|
145.60 mg/dL
Standard Deviation 22.763
|
144.27 mg/dL
Standard Deviation 14.701
|
141.68 mg/dL
Standard Deviation 20.412
|
148.48 mg/dL
Standard Deviation 18.012
|
149.17 mg/dL
Standard Deviation 23.566
|
144.08 mg/dL
Standard Deviation 18.630
|
148.75 mg/dL
Standard Deviation 17.738
|
150.04 mg/dL
Standard Deviation 23.145
|
144.48 mg/dL
Standard Deviation 15.237
|
|
Apolipoprotein A-I (ApoA-I)
Day 155
|
147.60 mg/dL
Standard Deviation 23.076
|
147.09 mg/dL
Standard Deviation 16.446
|
140.96 mg/dL
Standard Deviation 23.437
|
148.09 mg/dL
Standard Deviation 21.037
|
149.13 mg/dL
Standard Deviation 23.899
|
143.52 mg/dL
Standard Deviation 17.564
|
148.83 mg/dL
Standard Deviation 20.267
|
149.52 mg/dL
Standard Deviation 21.848
|
148.83 mg/dL
Standard Deviation 18.077
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Change at Day 113
|
-7.86 mg/dL
Standard Deviation 13.052
|
-0.34 mg/dL
Standard Deviation 10.783
|
-0.50 mg/dL
Standard Deviation 9.512
|
1.87 mg/dL
Standard Deviation 9.328
|
-3.54 mg/dL
Standard Deviation 8.982
|
2.52 mg/dL
Standard Deviation 9.226
|
6.56 mg/dL
Standard Deviation 12.310
|
3.72 mg/dL
Standard Deviation 11.977
|
-10.09 mg/dL
Standard Deviation 11.236
|
|
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Change at Day 85
|
-9.65 mg/dL
Standard Deviation 9.495
|
-1.11 mg/dL
Standard Deviation 11.118
|
-6.02 mg/dL
Standard Deviation 11.069
|
-2.09 mg/dL
Standard Deviation 12.040
|
-0.17 mg/dL
Standard Deviation 11.897
|
1.02 mg/dL
Standard Deviation 9.479
|
5.56 mg/dL
Standard Deviation 10.575
|
3.63 mg/dL
Standard Deviation 11.155
|
-13.83 mg/dL
Standard Deviation 10.602
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Change at Day 85
|
-6.44 percent change
Standard Deviation 6.252
|
-0.34 percent change
Standard Deviation 7.749
|
-3.82 percent change
Standard Deviation 8.033
|
-1.00 percent change
Standard Deviation 8.245
|
0.44 percent change
Standard Deviation 8.673
|
0.87 percent change
Standard Deviation 7.002
|
4.20 percent change
Standard Deviation 7.438
|
3.26 percent change
Standard Deviation 8.418
|
-9.10 percent change
Standard Deviation 6.738
|
|
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Change at Day 113
|
-5.16 percent change
Standard Deviation 8.106
|
0.15 percent change
Standard Deviation 7.819
|
0.13 percent change
Standard Deviation 7.013
|
1.53 percent change
Standard Deviation 6.572
|
-1.84 percent change
Standard Deviation 5.923
|
1.93 percent change
Standard Deviation 6.789
|
4.82 percent change
Standard Deviation 8.766
|
3.13 percent change
Standard Deviation 8.663
|
-6.55 percent change
Standard Deviation 6.903
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apolipoprotein A-II (ApoA-II)
Day 5
|
31.608 mg/dL
Standard Deviation 3.6099
|
32.709 mg/dL
Standard Deviation 3.4130
|
30.088 mg/dL
Standard Deviation 3.4784
|
30.972 mg/dL
Standard Deviation 4.2462
|
30.558 mg/dL
Standard Deviation 3.0567
|
30.884 mg/dL
Standard Deviation 3.6551
|
30.161 mg/dL
Standard Deviation 2.9004
|
30.443 mg/dL
Standard Deviation 3.4057
|
31.473 mg/dL
Standard Deviation 4.1750
|
|
Apolipoprotein A-II (ApoA-II)
Day 8
|
32.036 mg/dL
Standard Deviation 3.2261
|
32.495 mg/dL
Standard Deviation 3.0372
|
30.760 mg/dL
Standard Deviation 3.3363
|
30.608 mg/dL
Standard Deviation 3.8492
|
30.664 mg/dL
Standard Deviation 3.2942
|
30.224 mg/dL
Standard Deviation 2.8736
|
30.675 mg/dL
Standard Deviation 3.1077
|
30.738 mg/dL
Standard Deviation 2.9137
|
31.635 mg/dL
Standard Deviation 3.6272
|
|
Apolipoprotein A-II (ApoA-II)
Day 36
|
31.150 mg/dL
Standard Deviation 3.3011
|
32.091 mg/dL
Standard Deviation 4.0243
|
29.768 mg/dL
Standard Deviation 3.2825
|
31.404 mg/dL
Standard Deviation 4.0581
|
30.975 mg/dL
Standard Deviation 3.3526
|
31.208 mg/dL
Standard Deviation 3.5747
|
30.838 mg/dL
Standard Deviation 3.3920
|
30.622 mg/dL
Standard Deviation 3.3870
|
31.478 mg/dL
Standard Deviation 3.7066
|
|
Apolipoprotein A-II (ApoA-II)
Day 57
|
30.773 mg/dL
Standard Deviation 3.4292
|
32.405 mg/dL
Standard Deviation 3.0798
|
28.548 mg/dL
Standard Deviation 3.8710
|
31.454 mg/dL
Standard Deviation 4.3687
|
30.033 mg/dL
Standard Deviation 3.9031
|
30.708 mg/dL
Standard Deviation 5.1285
|
30.271 mg/dL
Standard Deviation 4.0390
|
29.987 mg/dL
Standard Deviation 3.2086
|
29.861 mg/dL
Standard Deviation 3.3007
|
|
Apolipoprotein A-II (ApoA-II)
Day 127
|
31.824 mg/dL
Standard Deviation 3.4922
|
32.905 mg/dL
Standard Deviation 3.2614
|
30.904 mg/dL
Standard Deviation 3.1115
|
32.374 mg/dL
Standard Deviation 3.7973
|
31.242 mg/dL
Standard Deviation 3.5215
|
32.068 mg/dL
Standard Deviation 3.9869
|
31.358 mg/dL
Standard Deviation 3.9263
|
31.370 mg/dL
Standard Deviation 3.4158
|
31.839 mg/dL
Standard Deviation 3.7256
|
|
Apolipoprotein A-II (ApoA-II)
Day 141
|
32.044 mg/dL
Standard Deviation 4.2146
|
32.818 mg/dL
Standard Deviation 3.4188
|
31.412 mg/dL
Standard Deviation 3.6261
|
33.287 mg/dL
Standard Deviation 3.0694
|
32.029 mg/dL
Standard Deviation 3.4970
|
32.704 mg/dL
Standard Deviation 4.5005
|
32.325 mg/dL
Standard Deviation 4.2787
|
32.835 mg/dL
Standard Deviation 3.3582
|
32.178 mg/dL
Standard Deviation 3.1213
|
|
Apolipoprotein A-II (ApoA-II)
Day 155
|
31.956 mg/dL
Standard Deviation 4.1374
|
32.877 mg/dL
Standard Deviation 3.7858
|
31.061 mg/dL
Standard Deviation 3.8024
|
32.891 mg/dL
Standard Deviation 4.0870
|
31.867 mg/dL
Standard Deviation 3.6487
|
32.164 mg/dL
Standard Deviation 3.9476
|
31.629 mg/dL
Standard Deviation 4.4463
|
31.878 mg/dL
Standard Deviation 3.3637
|
31.439 mg/dL
Standard Deviation 3.4050
|
|
Apolipoprotein A-II (ApoA-II)
Baseline
|
31.515 mg/dL
Standard Deviation 3.8373
|
32.189 mg/dL
Standard Deviation 3.2855
|
29.940 mg/dL
Standard Deviation 3.3630
|
31.232 mg/dL
Standard Deviation 3.9681
|
30.294 mg/dL
Standard Deviation 3.0541
|
30.700 mg/dL
Standard Deviation 3.6817
|
30.223 mg/dL
Standard Deviation 2.8992
|
30.471 mg/dL
Standard Deviation 2.8918
|
31.354 mg/dL
Standard Deviation 3.9552
|
|
Apolipoprotein A-II (ApoA-II)
Day 15
|
32.062 mg/dL
Standard Deviation 3.2968
|
33.136 mg/dL
Standard Deviation 3.6822
|
30.568 mg/dL
Standard Deviation 3.3308
|
31.516 mg/dL
Standard Deviation 3.9116
|
31.275 mg/dL
Standard Deviation 3.4925
|
30.528 mg/dL
Standard Deviation 3.7034
|
31.129 mg/dL
Standard Deviation 2.9304
|
31.304 mg/dL
Standard Deviation 3.0309
|
31.530 mg/dL
Standard Deviation 4.6451
|
|
Apolipoprotein A-II (ApoA-II)
Day 85
|
30.577 mg/dL
Standard Deviation 4.1019
|
33.095 mg/dL
Standard Deviation 3.4642
|
29.036 mg/dL
Standard Deviation 3.6811
|
31.957 mg/dL
Standard Deviation 4.8917
|
30.533 mg/dL
Standard Deviation 4.0376
|
30.484 mg/dL
Standard Deviation 4.5441
|
30.296 mg/dL
Standard Deviation 4.2019
|
29.974 mg/dL
Standard Deviation 3.3766
|
29.657 mg/dL
Standard Deviation 3.6082
|
|
Apolipoprotein A-II (ApoA-II)
Day 99
|
32.500 mg/dL
Standard Deviation 4.3987
|
33.155 mg/dL
Standard Deviation 3.9087
|
31.352 mg/dL
Standard Deviation 3.8161
|
32.925 mg/dL
Standard Deviation 5.9562
|
31.229 mg/dL
Standard Deviation 2.9670
|
32.868 mg/dL
Standard Deviation 4.2145
|
32.054 mg/dL
Standard Deviation 4.3729
|
31.436 mg/dL
Standard Deviation 3.7821
|
31.570 mg/dL
Standard Deviation 4.3204
|
|
Apolipoprotein A-II (ApoA-II)
Day 106
|
31.724 mg/dL
Standard Deviation 3.5444
|
32.432 mg/dL
Standard Deviation 3.6429
|
30.520 mg/dL
Standard Deviation 3.9332
|
32.552 mg/dL
Standard Deviation 4.3131
|
31.438 mg/dL
Standard Deviation 3.7623
|
31.908 mg/dL
Standard Deviation 4.1181
|
31.850 mg/dL
Standard Deviation 3.8284
|
31.073 mg/dL
Standard Deviation 3.3504
|
30.865 mg/dL
Standard Deviation 3.7092
|
|
Apolipoprotein A-II (ApoA-II)
Day 113
|
30.388 mg/dL
Standard Deviation 3.3572
|
32.559 mg/dL
Standard Deviation 3.0055
|
29.300 mg/dL
Standard Deviation 3.3821
|
32.361 mg/dL
Standard Deviation 4.1480
|
30.239 mg/dL
Standard Deviation 3.2747
|
30.442 mg/dL
Standard Deviation 4.1097
|
30.313 mg/dL
Standard Deviation 4.1545
|
29.787 mg/dL
Standard Deviation 3.3975
|
30.126 mg/dL
Standard Deviation 3.5101
|
|
Apolipoprotein A-II (ApoA-II)
Day 169
|
33.120 mg/dL
Standard Deviation 4.2339
|
33.623 mg/dL
Standard Deviation 4.2722
|
31.433 mg/dL
Standard Deviation 3.8678
|
33.578 mg/dL
Standard Deviation 4.4671
|
32.070 mg/dL
Standard Deviation 3.9987
|
31.848 mg/dL
Standard Deviation 4.1778
|
32.033 mg/dL
Standard Deviation 3.8588
|
32.352 mg/dL
Standard Deviation 3.8903
|
32.345 mg/dL
Standard Deviation 3.6908
|
|
Apolipoprotein A-II (ApoA-II)
Day 22
|
31.846 mg/dL
Standard Deviation 3.0899
|
32.273 mg/dL
Standard Deviation 3.2310
|
30.620 mg/dL
Standard Deviation 3.3448
|
31.125 mg/dL
Standard Deviation 4.0921
|
30.896 mg/dL
Standard Deviation 3.0900
|
31.232 mg/dL
Standard Deviation 3.1787
|
30.667 mg/dL
Standard Deviation 3.4561
|
31.183 mg/dL
Standard Deviation 3.8763
|
32.200 mg/dL
Standard Deviation 3.6940
|
|
Apolipoprotein A-II (ApoA-II)
Day 29
|
32.096 mg/dL
Standard Deviation 3.6363
|
32.395 mg/dL
Standard Deviation 3.1748
|
30.740 mg/dL
Standard Deviation 3.0899
|
31.100 mg/dL
Standard Deviation 3.6272
|
31.071 mg/dL
Standard Deviation 2.8639
|
31.608 mg/dL
Standard Deviation 3.2712
|
32.279 mg/dL
Standard Deviation 4.1331
|
31.035 mg/dL
Standard Deviation 3.7585
|
31.882 mg/dL
Standard Deviation 3.6960
|
|
Apolipoprotein A-II (ApoA-II)
Day 43
|
31.685 mg/dL
Standard Deviation 3.6743
|
32.636 mg/dL
Standard Deviation 3.1568
|
30.720 mg/dL
Standard Deviation 3.6371
|
32.408 mg/dL
Standard Deviation 4.0300
|
31.138 mg/dL
Standard Deviation 3.4691
|
31.600 mg/dL
Standard Deviation 3.8155
|
31.908 mg/dL
Standard Deviation 4.2809
|
31.004 mg/dL
Standard Deviation 3.6090
|
31.922 mg/dL
Standard Deviation 3.8381
|
|
Apolipoprotein A-II (ApoA-II)
Day 50
|
31.900 mg/dL
Standard Deviation 3.5621
|
32.282 mg/dL
Standard Deviation 3.5327
|
29.760 mg/dL
Standard Deviation 3.8077
|
32.704 mg/dL
Standard Deviation 3.8668
|
31.083 mg/dL
Standard Deviation 3.8423
|
31.772 mg/dL
Standard Deviation 3.9676
|
31.117 mg/dL
Standard Deviation 3.5511
|
30.991 mg/dL
Standard Deviation 2.9264
|
30.830 mg/dL
Standard Deviation 3.7644
|
|
Apolipoprotein A-II (ApoA-II)
Day 71
|
32.092 mg/dL
Standard Deviation 3.5748
|
33.127 mg/dL
Standard Deviation 3.3208
|
30.260 mg/dL
Standard Deviation 3.9125
|
32.658 mg/dL
Standard Deviation 3.9677
|
31.804 mg/dL
Standard Deviation 3.5119
|
32.600 mg/dL
Standard Deviation 4.3091
|
31.554 mg/dL
Standard Deviation 4.3823
|
31.148 mg/dL
Standard Deviation 2.8016
|
31.317 mg/dL
Standard Deviation 4.0283
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Change at Day 85
|
-0.938 mg/dL
Standard Deviation 1.8339
|
0.907 mg/dL
Standard Deviation 2.6785
|
-0.904 mg/dL
Standard Deviation 2.3894
|
0.354 mg/dL
Standard Deviation 3.3769
|
0.240 mg/dL
Standard Deviation 3.1812
|
-0.216 mg/dL
Standard Deviation 2.2274
|
0.073 mg/dL
Standard Deviation 2.6605
|
-0.450 mg/dL
Standard Deviation 2.3906
|
-1.698 mg/dL
Standard Deviation 2.9589
|
|
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Change at Day 113
|
-1.104 mg/dL
Standard Deviation 4.0438
|
0.370 mg/dL
Standard Deviation 2.2388
|
-0.640 mg/dL
Standard Deviation 2.0394
|
0.759 mg/dL
Standard Deviation 2.2739
|
0.002 mg/dL
Standard Deviation 2.8256
|
-0.073 mg/dL
Standard Deviation 2.0937
|
0.090 mg/dL
Standard Deviation 2.3882
|
-0.637 mg/dL
Standard Deviation 2.2412
|
-1.228 mg/dL
Standard Deviation 3.4404
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Change at Day 85
|
-2.93 percent change
Standard Deviation 5.741
|
3.13 percent change
Standard Deviation 8.288
|
-2.87 percent change
Standard Deviation 7.788
|
1.34 percent change
Standard Deviation 10.779
|
0.98 percent change
Standard Deviation 10.565
|
-0.85 percent change
Standard Deviation 7.387
|
0.17 percent change
Standard Deviation 8.699
|
-1.34 percent change
Standard Deviation 7.672
|
-4.97 percent change
Standard Deviation 9.262
|
|
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Change at Day 113
|
-2.77 percent change
Standard Deviation 11.234
|
1.48 percent change
Standard Deviation 6.776
|
-1.94 percent change
Standard Deviation 6.337
|
2.64 percent change
Standard Deviation 7.315
|
0.39 percent change
Standard Deviation 9.526
|
-0.21 percent change
Standard Deviation 6.972
|
0.13 percent change
Standard Deviation 7.974
|
-1.99 percent change
Standard Deviation 7.403
|
-3.29 percent change
Standard Deviation 10.137
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Lipoprotein (a) (Lp[a])
Day 8
|
19.184 mg/dL
Standard Deviation 14.7461
|
17.243 mg/dL
Standard Deviation 15.7353
|
12.000 mg/dL
Standard Deviation 11.8358
|
12.617 mg/dL
Standard Deviation 10.4189
|
12.768 mg/dL
Standard Deviation 8.9168
|
14.892 mg/dL
Standard Deviation 13.2944
|
15.333 mg/dL
Standard Deviation 18.3499
|
14.167 mg/dL
Standard Deviation 15.5022
|
16.443 mg/dL
Standard Deviation 12.1793
|
|
Lipoprotein (a) (Lp[a])
Day 15
|
19.258 mg/dL
Standard Deviation 16.0484
|
18.982 mg/dL
Standard Deviation 20.4348
|
10.140 mg/dL
Standard Deviation 10.0017
|
12.548 mg/dL
Standard Deviation 10.9860
|
9.996 mg/dL
Standard Deviation 8.1113
|
14.208 mg/dL
Standard Deviation 12.9280
|
14.129 mg/dL
Standard Deviation 17.8567
|
11.392 mg/dL
Standard Deviation 14.1251
|
16.443 mg/dL
Standard Deviation 11.4594
|
|
Lipoprotein (a) (Lp[a])
Day 36
|
17.046 mg/dL
Standard Deviation 14.4893
|
18.050 mg/dL
Standard Deviation 19.5448
|
9.484 mg/dL
Standard Deviation 10.6692
|
10.329 mg/dL
Standard Deviation 9.7943
|
8.067 mg/dL
Standard Deviation 6.7186
|
11.152 mg/dL
Standard Deviation 11.9088
|
12.833 mg/dL
Standard Deviation 16.0418
|
10.409 mg/dL
Standard Deviation 12.7145
|
15.843 mg/dL
Standard Deviation 10.8050
|
|
Lipoprotein (a) (Lp[a])
Day 57
|
15.892 mg/dL
Standard Deviation 14.0990
|
17.573 mg/dL
Standard Deviation 21.9401
|
9.392 mg/dL
Standard Deviation 10.2457
|
9.487 mg/dL
Standard Deviation 8.2801
|
6.858 mg/dL
Standard Deviation 6.2894
|
10.708 mg/dL
Standard Deviation 10.3883
|
10.871 mg/dL
Standard Deviation 13.5224
|
8.578 mg/dL
Standard Deviation 11.2275
|
14.313 mg/dL
Standard Deviation 9.3930
|
|
Lipoprotein (a) (Lp[a])
Day 85
|
16.519 mg/dL
Standard Deviation 14.5691
|
17.609 mg/dL
Standard Deviation 19.7001
|
8.808 mg/dL
Standard Deviation 10.3417
|
9.261 mg/dL
Standard Deviation 7.6804
|
6.637 mg/dL
Standard Deviation 5.6695
|
10.960 mg/dL
Standard Deviation 11.6806
|
10.879 mg/dL
Standard Deviation 14.1289
|
9.239 mg/dL
Standard Deviation 11.1448
|
12.726 mg/dL
Standard Deviation 8.9598
|
|
Lipoprotein (a) (Lp[a])
Day 169
|
15.384 mg/dL
Standard Deviation 13.7150
|
17.059 mg/dL
Standard Deviation 20.8409
|
11.271 mg/dL
Standard Deviation 11.4561
|
13.613 mg/dL
Standard Deviation 11.5074
|
10.626 mg/dL
Standard Deviation 8.0902
|
17.824 mg/dL
Standard Deviation 15.1879
|
17.404 mg/dL
Standard Deviation 18.0405
|
16.635 mg/dL
Standard Deviation 17.8211
|
14.741 mg/dL
Standard Deviation 10.3647
|
|
Lipoprotein (a) (Lp[a])
Baseline
|
19.265 mg/dL
Standard Deviation 14.3646
|
19.468 mg/dL
Standard Deviation 18.4181
|
14.080 mg/dL
Standard Deviation 11.9369
|
15.458 mg/dL
Standard Deviation 12.6296
|
13.400 mg/dL
Standard Deviation 9.0719
|
18.452 mg/dL
Standard Deviation 13.1792
|
20.998 mg/dL
Standard Deviation 17.2111
|
18.840 mg/dL
Standard Deviation 16.7289
|
16.239 mg/dL
Standard Deviation 10.1883
|
|
Lipoprotein (a) (Lp[a])
Day 5
|
18.523 mg/dL
Standard Deviation 15.2512
|
20.450 mg/dL
Standard Deviation 18.8904
|
12.464 mg/dL
Standard Deviation 10.5751
|
14.580 mg/dL
Standard Deviation 12.2541
|
11.783 mg/dL
Standard Deviation 9.3506
|
16.224 mg/dL
Standard Deviation 13.4935
|
18.348 mg/dL
Standard Deviation 17.7316
|
16.204 mg/dL
Standard Deviation 16.6072
|
15.859 mg/dL
Standard Deviation 10.9932
|
|
Lipoprotein (a) (Lp[a])
Day 22
|
18.785 mg/dL
Standard Deviation 16.0604
|
17.800 mg/dL
Standard Deviation 18.6499
|
10.936 mg/dL
Standard Deviation 10.1920
|
11.583 mg/dL
Standard Deviation 11.3914
|
8.800 mg/dL
Standard Deviation 7.1835
|
12.628 mg/dL
Standard Deviation 12.4393
|
12.446 mg/dL
Standard Deviation 16.1397
|
10.765 mg/dL
Standard Deviation 13.3504
|
16.026 mg/dL
Standard Deviation 11.0080
|
|
Lipoprotein (a) (Lp[a])
Day 29
|
18.304 mg/dL
Standard Deviation 15.6050
|
17.873 mg/dL
Standard Deviation 18.0678
|
10.424 mg/dL
Standard Deviation 10.6085
|
10.888 mg/dL
Standard Deviation 9.8450
|
9.312 mg/dL
Standard Deviation 7.3675
|
12.832 mg/dL
Standard Deviation 12.3874
|
13.379 mg/dL
Standard Deviation 16.2405
|
10.552 mg/dL
Standard Deviation 12.7986
|
17.423 mg/dL
Standard Deviation 11.1746
|
|
Lipoprotein (a) (Lp[a])
Day 43
|
16.912 mg/dL
Standard Deviation 14.1356
|
17.214 mg/dL
Standard Deviation 18.6825
|
9.380 mg/dL
Standard Deviation 9.6416
|
9.944 mg/dL
Standard Deviation 9.7431
|
8.821 mg/dL
Standard Deviation 7.6426
|
11.648 mg/dL
Standard Deviation 12.2798
|
12.525 mg/dL
Standard Deviation 16.1360
|
9.633 mg/dL
Standard Deviation 12.4360
|
15.961 mg/dL
Standard Deviation 10.3890
|
|
Lipoprotein (a) (Lp[a])
Day 50
|
16.835 mg/dL
Standard Deviation 14.2068
|
17.314 mg/dL
Standard Deviation 19.6439
|
10.040 mg/dL
Standard Deviation 10.4835
|
10.191 mg/dL
Standard Deviation 9.2630
|
7.621 mg/dL
Standard Deviation 6.5659
|
10.344 mg/dL
Standard Deviation 11.3684
|
11.675 mg/dL
Standard Deviation 14.8818
|
9.039 mg/dL
Standard Deviation 12.0250
|
15.078 mg/dL
Standard Deviation 9.7608
|
|
Lipoprotein (a) (Lp[a])
Day 71
|
16.542 mg/dL
Standard Deviation 13.5029
|
16.991 mg/dL
Standard Deviation 20.0151
|
9.248 mg/dL
Standard Deviation 11.4972
|
9.529 mg/dL
Standard Deviation 8.6412
|
6.979 mg/dL
Standard Deviation 6.5414
|
11.358 mg/dL
Standard Deviation 12.3793
|
11.354 mg/dL
Standard Deviation 14.0492
|
9.009 mg/dL
Standard Deviation 11.7733
|
13.500 mg/dL
Standard Deviation 9.4333
|
|
Lipoprotein (a) (Lp[a])
Day 99
|
15.764 mg/dL
Standard Deviation 14.4527
|
16.868 mg/dL
Standard Deviation 19.6709
|
7.940 mg/dL
Standard Deviation 9.6343
|
8.537 mg/dL
Standard Deviation 7.6094
|
6.792 mg/dL
Standard Deviation 5.6212
|
12.232 mg/dL
Standard Deviation 12.5326
|
11.837 mg/dL
Standard Deviation 15.6082
|
8.855 mg/dL
Standard Deviation 13.9399
|
13.691 mg/dL
Standard Deviation 9.5937
|
|
Lipoprotein (a) (Lp[a])
Day 106
|
15.396 mg/dL
Standard Deviation 12.8944
|
16.682 mg/dL
Standard Deviation 18.8434
|
8.608 mg/dL
Standard Deviation 9.5662
|
8.296 mg/dL
Standard Deviation 7.3410
|
6.858 mg/dL
Standard Deviation 6.1058
|
10.756 mg/dL
Standard Deviation 11.7377
|
11.079 mg/dL
Standard Deviation 14.2590
|
9.123 mg/dL
Standard Deviation 14.1064
|
12.800 mg/dL
Standard Deviation 8.9601
|
|
Lipoprotein (a) (Lp[a])
Day 113
|
14.492 mg/dL
Standard Deviation 12.9060
|
16.814 mg/dL
Standard Deviation 17.8976
|
8.020 mg/dL
Standard Deviation 9.0412
|
8.287 mg/dL
Standard Deviation 7.6439
|
6.787 mg/dL
Standard Deviation 5.8743
|
12.108 mg/dL
Standard Deviation 12.3479
|
11.183 mg/dL
Standard Deviation 14.5312
|
9.565 mg/dL
Standard Deviation 14.0691
|
12.913 mg/dL
Standard Deviation 9.7212
|
|
Lipoprotein (a) (Lp[a])
Day 127
|
15.500 mg/dL
Standard Deviation 13.0255
|
16.618 mg/dL
Standard Deviation 19.1791
|
9.864 mg/dL
Standard Deviation 10.2016
|
10.543 mg/dL
Standard Deviation 9.2205
|
7.642 mg/dL
Standard Deviation 6.9977
|
15.476 mg/dL
Standard Deviation 14.6308
|
15.112 mg/dL
Standard Deviation 16.5781
|
11.961 mg/dL
Standard Deviation 15.6073
|
13.596 mg/dL
Standard Deviation 9.3340
|
|
Lipoprotein (a) (Lp[a])
Day 141
|
15.828 mg/dL
Standard Deviation 13.7114
|
17.236 mg/dL
Standard Deviation 18.8525
|
10.100 mg/dL
Standard Deviation 10.9325
|
11.996 mg/dL
Standard Deviation 10.0494
|
8.442 mg/dL
Standard Deviation 6.7945
|
16.842 mg/dL
Standard Deviation 15.6809
|
17.329 mg/dL
Standard Deviation 18.9837
|
14.422 mg/dL
Standard Deviation 17.3620
|
13.139 mg/dL
Standard Deviation 9.2951
|
|
Lipoprotein (a) (Lp[a])
Day 155
|
16.004 mg/dL
Standard Deviation 13.7418
|
17.382 mg/dL
Standard Deviation 19.8297
|
10.204 mg/dL
Standard Deviation 11.2720
|
13.465 mg/dL
Standard Deviation 10.8114
|
9.600 mg/dL
Standard Deviation 7.5028
|
17.264 mg/dL
Standard Deviation 15.4506
|
17.483 mg/dL
Standard Deviation 19.9385
|
16.052 mg/dL
Standard Deviation 16.9174
|
13.183 mg/dL
Standard Deviation 9.1710
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Change at Day 85
|
-2.746 mg/dL
Standard Deviation 3.1292
|
-1.859 mg/dL
Standard Deviation 3.0759
|
-5.272 mg/dL
Standard Deviation 5.1528
|
-7.100 mg/dL
Standard Deviation 5.9402
|
-6.763 mg/dL
Standard Deviation 5.3474
|
-7.492 mg/dL
Standard Deviation 5.1400
|
-10.119 mg/dL
Standard Deviation 5.4374
|
-10.239 mg/dL
Standard Deviation 8.2471
|
-3.513 mg/dL
Standard Deviation 3.6550
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Change at Day 113
|
-3.574 mg/dL
Standard Deviation 4.0251
|
-2.655 mg/dL
Standard Deviation 3.1725
|
-6.060 mg/dL
Standard Deviation 4.5477
|
-8.074 mg/dL
Standard Deviation 6.0886
|
-7.098 mg/dL
Standard Deviation 4.5025
|
-6.815 mg/dL
Standard Deviation 4.6182
|
-9.815 mg/dL
Standard Deviation 5.0568
|
-9.913 mg/dL
Standard Deviation 6.6763
|
-3.326 mg/dL
Standard Deviation 3.4975
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Change at Day 85
|
-19.37 percent change
Standard Deviation 25.160
|
-15.22 percent change
Standard Deviation 23.532
|
-37.85 percent change
Standard Deviation 27.223
|
-37.29 percent change
Standard Deviation 24.552
|
-43.37 percent change
Standard Deviation 39.755
|
-47.11 percent change
Standard Deviation 20.802
|
-58.53 percent change
Standard Deviation 22.181
|
-46.51 percent change
Standard Deviation 63.192
|
-18.40 percent change
Standard Deviation 30.139
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Change at Day 113
|
-24.35 percent change
Standard Deviation 21.348
|
-18.64 percent change
Standard Deviation 18.300
|
-45.26 percent change
Standard Deviation 22.490
|
-47.60 percent change
Standard Deviation 19.448
|
-49.77 percent change
Standard Deviation 25.417
|
-42.30 percent change
Standard Deviation 19.223
|
-57.94 percent change
Standard Deviation 22.317
|
-59.42 percent change
Standard Deviation 21.689
|
-15.89 percent change
Standard Deviation 36.642
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 8
|
60.52 mg/dL
Standard Deviation 14.234
|
58.67 mg/dL
Standard Deviation 10.136
|
59.60 mg/dL
Standard Deviation 15.729
|
61.33 mg/dL
Standard Deviation 14.230
|
64.00 mg/dL
Standard Deviation 23.420
|
56.48 mg/dL
Standard Deviation 11.266
|
58.38 mg/dL
Standard Deviation 12.700
|
60.33 mg/dL
Standard Deviation 13.017
|
60.57 mg/dL
Standard Deviation 11.289
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 29
|
57.96 mg/dL
Standard Deviation 13.192
|
59.00 mg/dL
Standard Deviation 9.587
|
60.84 mg/dL
Standard Deviation 16.222
|
62.52 mg/dL
Standard Deviation 15.196
|
67.96 mg/dL
Standard Deviation 20.412
|
59.96 mg/dL
Standard Deviation 10.486
|
61.75 mg/dL
Standard Deviation 13.553
|
63.83 mg/dL
Standard Deviation 15.948
|
64.14 mg/dL
Standard Deviation 9.896
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 36
|
57.62 mg/dL
Standard Deviation 13.518
|
58.23 mg/dL
Standard Deviation 10.314
|
59.76 mg/dL
Standard Deviation 14.521
|
65.25 mg/dL
Standard Deviation 14.411
|
65.21 mg/dL
Standard Deviation 19.489
|
57.92 mg/dL
Standard Deviation 10.622
|
60.50 mg/dL
Standard Deviation 13.112
|
62.39 mg/dL
Standard Deviation 14.151
|
59.91 mg/dL
Standard Deviation 10.833
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Baseline
|
58.54 mg/dL
Standard Deviation 14.683
|
56.98 mg/dL
Standard Deviation 9.607
|
57.22 mg/dL
Standard Deviation 14.146
|
60.40 mg/dL
Standard Deviation 13.228
|
62.02 mg/dL
Standard Deviation 21.455
|
54.58 mg/dL
Standard Deviation 9.048
|
54.75 mg/dL
Standard Deviation 11.789
|
57.00 mg/dL
Standard Deviation 12.858
|
60.87 mg/dL
Standard Deviation 10.606
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 5
|
58.19 mg/dL
Standard Deviation 14.403
|
57.00 mg/dL
Standard Deviation 9.866
|
57.20 mg/dL
Standard Deviation 15.785
|
60.32 mg/dL
Standard Deviation 13.643
|
62.08 mg/dL
Standard Deviation 21.354
|
55.68 mg/dL
Standard Deviation 11.131
|
57.04 mg/dL
Standard Deviation 12.532
|
58.43 mg/dL
Standard Deviation 13.480
|
59.73 mg/dL
Standard Deviation 11.344
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 15
|
59.35 mg/dL
Standard Deviation 15.179
|
60.23 mg/dL
Standard Deviation 12.208
|
60.24 mg/dL
Standard Deviation 16.048
|
62.32 mg/dL
Standard Deviation 15.513
|
66.58 mg/dL
Standard Deviation 22.085
|
58.52 mg/dL
Standard Deviation 8.637
|
59.96 mg/dL
Standard Deviation 11.925
|
62.79 mg/dL
Standard Deviation 15.562
|
60.30 mg/dL
Standard Deviation 11.117
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 22
|
58.08 mg/dL
Standard Deviation 12.743
|
60.05 mg/dL
Standard Deviation 10.017
|
60.92 mg/dL
Standard Deviation 16.253
|
63.92 mg/dL
Standard Deviation 13.529
|
65.38 mg/dL
Standard Deviation 17.358
|
59.36 mg/dL
Standard Deviation 11.158
|
60.08 mg/dL
Standard Deviation 12.176
|
64.52 mg/dL
Standard Deviation 14.585
|
61.48 mg/dL
Standard Deviation 11.233
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 43
|
57.31 mg/dL
Standard Deviation 13.936
|
58.82 mg/dL
Standard Deviation 10.450
|
59.36 mg/dL
Standard Deviation 14.950
|
63.64 mg/dL
Standard Deviation 15.435
|
65.17 mg/dL
Standard Deviation 18.846
|
59.76 mg/dL
Standard Deviation 8.724
|
62.21 mg/dL
Standard Deviation 13.266
|
62.29 mg/dL
Standard Deviation 15.415
|
59.74 mg/dL
Standard Deviation 10.558
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 50
|
57.81 mg/dL
Standard Deviation 14.525
|
58.55 mg/dL
Standard Deviation 10.835
|
59.40 mg/dL
Standard Deviation 14.955
|
64.91 mg/dL
Standard Deviation 13.651
|
65.21 mg/dL
Standard Deviation 19.669
|
60.12 mg/dL
Standard Deviation 10.248
|
60.04 mg/dL
Standard Deviation 12.185
|
62.09 mg/dL
Standard Deviation 14.058
|
59.39 mg/dL
Standard Deviation 10.586
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 57
|
54.88 mg/dL
Standard Deviation 12.745
|
57.45 mg/dL
Standard Deviation 10.804
|
57.16 mg/dL
Standard Deviation 12.589
|
61.92 mg/dL
Standard Deviation 14.374
|
62.63 mg/dL
Standard Deviation 20.549
|
58.40 mg/dL
Standard Deviation 8.221
|
58.83 mg/dL
Standard Deviation 13.830
|
60.35 mg/dL
Standard Deviation 13.231
|
56.61 mg/dL
Standard Deviation 10.782
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 71
|
56.85 mg/dL
Standard Deviation 12.069
|
58.00 mg/dL
Standard Deviation 9.798
|
59.16 mg/dL
Standard Deviation 13.539
|
63.92 mg/dL
Standard Deviation 14.185
|
66.29 mg/dL
Standard Deviation 20.354
|
60.29 mg/dL
Standard Deviation 9.438
|
62.96 mg/dL
Standard Deviation 14.0492
|
64.83 mg/dL
Standard Deviation 16.854
|
57.78 mg/dL
Standard Deviation 9.662
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 85
|
53.96 mg/dL
Standard Deviation 12.981
|
59.77 mg/dL
Standard Deviation 10.438
|
55.04 mg/dL
Standard Deviation 13.421
|
63.09 mg/dL
Standard Deviation 13.211
|
62.00 mg/dL
Standard Deviation 17.619
|
58.24 mg/dL
Standard Deviation 9.926
|
59.54 mg/dL
Standard Deviation 12.827
|
59.70 mg/dL
Standard Deviation 11.315
|
56.35 mg/dL
Standard Deviation 10.075
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 99
|
59.92 mg/dL
Standard Deviation 12.812
|
60.36 mg/dL
Standard Deviation 10.472
|
60.00 mg/dL
Standard Deviation 13.051
|
64.54 mg/dL
Standard Deviation 15.453
|
64.63 mg/dL
Standard Deviation 18.946
|
62.68 mg/dL
Standard Deviation 11.926
|
62.54 mg/dL
Standard Deviation 13.462
|
62.32 mg/dL
Standard Deviation 14.496
|
59.30 mg/dL
Standard Deviation 12.430
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 106
|
58.28 mg/dL
Standard Deviation 12.651
|
59.45 mg/dL
Standard Deviation 10.117
|
60.08 mg/dL
Standard Deviation 15.231
|
64.39 mg/dL
Standard Deviation 15.718
|
65.17 mg/dL
Standard Deviation 18.897
|
62.36 mg/dL
Standard Deviation 11.489
|
63.25 mg/dL
Standard Deviation 15.118
|
64.41 mg/dL
Standard Deviation 13.355
|
58.30 mg/dL
Standard Deviation 11.703
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 113
|
55.28 mg/dL
Standard Deviation 13.145
|
60.32 mg/dL
Standard Deviation 10.049
|
57.92 mg/dL
Standard Deviation 14.617
|
63.00 mg/dL
Standard Deviation 14.331
|
61.83 mg/dL
Standard Deviation 18.218
|
58.13 mg/dL
Standard Deviation 11.395
|
61.04 mg/dL
Standard Deviation 14.245
|
59.39 mg/dL
Standard Deviation 12.565
|
56.17 mg/dL
Standard Deviation 10.421
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 127
|
60.72 mg/dL
Standard Deviation 15.118
|
57.82 mg/dL
Standard Deviation 9.272
|
58.56 mg/dL
Standard Deviation 13.818
|
63.61 mg/dL
Standard Deviation 16.160
|
63.88 mg/dL
Standard Deviation 19.161
|
59.16 mg/dL
Standard Deviation 12.212
|
59.46 mg/dL
Standard Deviation 13.552
|
62.78 mg/dL
Standard Deviation 14.013
|
58.00 mg/dL
Standard Deviation 10.838
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 141
|
60.96 mg/dL
Standard Deviation 15.970
|
59.09 mg/dL
Standard Deviation 10.766
|
59.40 mg/dL
Standard Deviation 16.081
|
63.26 mg/dL
Standard Deviation 14.229
|
64.00 mg/dL
Standard Deviation 20.167
|
60.58 mg/dL
Standard Deviation 11.960
|
60.63 mg/dL
Standard Deviation 13.682
|
64.26 mg/dL
Standard Deviation 14.530
|
62.39 mg/dL
Standard Deviation 14.138
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 155
|
59.48 mg/dL
Standard Deviation 14.535
|
59.45 mg/dL
Standard Deviation 9.179
|
59.04 mg/dL
Standard Deviation 16.425
|
63.00 mg/dL
Standard Deviation 15.021
|
63.67 mg/dL
Standard Deviation 20.550
|
58.72 mg/dL
Standard Deviation 10.620
|
59.00 mg/dL
Standard Deviation 14.341
|
61.96 mg/dL
Standard Deviation 14.455
|
61.87 mg/dL
Standard Deviation 13.602
|
|
High Density Lipoprotein- Cholesterol (HDL-C)
Day 169
|
61.88 mg/dL
Standard Deviation 15.078
|
60.50 mg/dL
Standard Deviation 11.827
|
60.29 mg/dL
Standard Deviation 16.206
|
62.04 mg/dL
Standard Deviation 15.155
|
65.00 mg/dL
Standard Deviation 24.355
|
57.48 mg/dL
Standard Deviation 11.794
|
59.04 mg/dL
Standard Deviation 12.726
|
62.48 mg/dL
Standard Deviation 14.441
|
65.05 mg/dL
Standard Deviation 13.584
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Change at Day 85
|
-4.58 mg/dL
Standard Deviation 4.573
|
2.80 mg/dL
Standard Deviation 6.223
|
-2.18 mg/dL
Standard Deviation 6.065
|
1.46 mg/dL
Standard Deviation 7.408
|
-0.02 mg/dL
Standard Deviation 7.575
|
3.66 mg/dL
Standard Deviation 6.216
|
4.79 mg/dL
Standard Deviation 5.568
|
2.63 mg/dL
Standard Deviation 5.394
|
-4.52 mg/dL
Standard Deviation 5.191
|
|
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Change at Day 113
|
-3.28 mg/dL
Standard Deviation 7.264
|
3.34 mg/dL
Standard Deviation 5.702
|
0.70 mg/dL
Standard Deviation 6.489
|
1.37 mg/dL
Standard Deviation 7.799
|
-0.63 mg/dL
Standard Deviation 6.995
|
3.90 mg/dL
Standard Deviation 6.437
|
6.29 mg/dL
Standard Deviation 7.003
|
2.33 mg/dL
Standard Deviation 8.053
|
-4.70 mg/dL
Standard Deviation 5.045
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Change at Day 85
|
-7.31 percent change
Standard Deviation 7.254
|
5.42 percent change
Standard Deviation 10.501
|
-3.10 percent change
Standard Deviation 10.471
|
2.93 percent change
Standard Deviation 11.259
|
2.35 percent change
Standard Deviation 12.101
|
7.26 percent change
Standard Deviation 10.914
|
9.46 percent change
Standard Deviation 11.132
|
5.86 percent change
Standard Deviation 9.988
|
-7.16 percent change
Standard Deviation 8.271
|
|
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Change at Day 113
|
-4.83 percent change
Standard Deviation 9.919
|
6.31 percent change
Standard Deviation 9.989
|
1.86 percent change
Standard Deviation 11.617
|
2.35 percent change
Standard Deviation 10.959
|
1.05 percent change
Standard Deviation 10.017
|
7.39 percent change
Standard Deviation 11.623
|
11.97 percent change
Standard Deviation 13.385
|
5.27 percent change
Standard Deviation 12.612
|
-7.53 percent change
Standard Deviation 7.966
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 8
|
21.72 mg/dL
Standard Deviation 10.577
|
20.29 mg/dL
Standard Deviation 7.100
|
18.64 mg/dL
Standard Deviation 9.995
|
16.25 mg/dL
Standard Deviation 6.661
|
18.95 mg/dL
Standard Deviation 9.810
|
19.64 mg/dL
Standard Deviation 13.073
|
18.00 mg/dL
Standard Deviation 6.574
|
15.58 mg/dL
Standard Deviation 6.192
|
22.48 mg/dL
Standard Deviation 13.737
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 22
|
21.65 mg/dL
Standard Deviation 7.573
|
21.59 mg/dL
Standard Deviation 7.866
|
17.20 mg/dL
Standard Deviation 7.984
|
16.42 mg/dL
Standard Deviation 6.580
|
17.17 mg/dL
Standard Deviation 14.199
|
17.04 mg/dL
Standard Deviation 6.761
|
19.04 mg/dL
Standard Deviation 7.410
|
14.65 mg/dL
Standard Deviation 6.786
|
18.13 mg/dL
Standard Deviation 9.416
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 29
|
21.88 mg/dL
Standard Deviation 9.523
|
22.73 mg/dL
Standard Deviation 10.552
|
17.00 mg/dL
Standard Deviation 7.746
|
19.68 mg/dL
Standard Deviation 16.106
|
13.04 mg/dL
Standard Deviation 6.753
|
15.76 mg/dL
Standard Deviation 7.253
|
19.88 mg/dL
Standard Deviation 9.967
|
15.39 mg/dL
Standard Deviation 4.717
|
19.00 mg/dL
Standard Deviation 8.258
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 36
|
21.92 mg/dL
Standard Deviation 9.587
|
21.59 mg/dL
Standard Deviation 9.169
|
17.28 mg/dL
Standard Deviation 6.901
|
16.46 mg/dL
Standard Deviation 6.129
|
15.50 mg/dL
Standard Deviation 5.905
|
18.96 mg/dL
Standard Deviation 9.361
|
15.33 mg/dL
Standard Deviation 4.984
|
14.04 mg/dL
Standard Deviation 5.842
|
24.22 mg/dL
Standard Deviation 17.231
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 43
|
23.65 mg/dL
Standard Deviation 12.547
|
20.95 mg/dL
Standard Deviation 7.712
|
20.00 mg/dL
Standard Deviation 7.708
|
18.12 mg/dL
Standard Deviation 7.316
|
16.96 mg/dL
Standard Deviation 6.734
|
16.56 mg/dL
Standard Deviation 6.246
|
21.33 mg/dL
Standard Deviation 13.770
|
18.04 mg/dL
Standard Deviation 10.813
|
22.78 mg/dL
Standard Deviation 11.631
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 50
|
21.69 mg/dL
Standard Deviation 11.235
|
19.23 mg/dL
Standard Deviation 6.718
|
17.48 mg/dL
Standard Deviation 8.186
|
17.04 mg/dL
Standard Deviation 7.151
|
15.54 mg/dL
Standard Deviation 7.818
|
16.36 mg/dL
Standard Deviation 9.269
|
17.67 mg/dL
Standard Deviation 6.787
|
14.39 mg/dL
Standard Deviation 6.966
|
22.26 mg/dL
Standard Deviation 13.685
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 71
|
21.77 mg/dL
Standard Deviation 9.868
|
20.82 mg/dL
Standard Deviation 8.151
|
19.04 mg/dL
Standard Deviation 6.846
|
16.79 mg/dL
Standard Deviation 6.840
|
14.63 mg/dL
Standard Deviation 6.337
|
15.92 mg/dL
Standard Deviation 7.064
|
17.50 mg/dL
Standard Deviation 9.212
|
13.83 mg/dL
Standard Deviation 3.950
|
22.61 mg/dL
Standard Deviation 9.014
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 85
|
22.58 mg/dL
Standard Deviation 7.991
|
19.77 mg/dL
Standard Deviation 5.936
|
16.68 mg/dL
Standard Deviation 7.040
|
14.09 mg/dL
Standard Deviation 6.735
|
14.04 mg/dL
Standard Deviation 4.639
|
14.24 mg/dL
Standard Deviation 6.247
|
17.63 mg/dL
Standard Deviation 8.816
|
14.04 mg/dL
Standard Deviation 6.745
|
16.43 mg/dL
Standard Deviation 8.877
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 99
|
21.72 mg/dL
Standard Deviation 11.085
|
20.14 mg/dL
Standard Deviation 7.298
|
17.84 mg/dL
Standard Deviation 6.756
|
16.46 mg/dL
Standard Deviation 9.514
|
16.21 mg/dL
Standard Deviation 8.490
|
16.20 mg/dL
Standard Deviation 6.371
|
18.04 mg/dL
Standard Deviation 10.378
|
18.68 mg/dL
Standard Deviation 17.700
|
21.13 mg/dL
Standard Deviation 8.981
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 106
|
19.32 mg/dL
Standard Deviation 7.330
|
18.64 mg/dL
Standard Deviation 6.499
|
17.76 mg/dL
Standard Deviation 7.573
|
16.09 mg/dL
Standard Deviation 5.672
|
13.13 mg/dL
Standard Deviation 5.788
|
14.44 mg/dL
Standard Deviation 6.545
|
15.96 mg/dL
Standard Deviation 6.328
|
14.59 mg/dL
Standard Deviation 5.981
|
20.00 mg/dL
Standard Deviation 9.376
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 113
|
21.88 mg/dL
Standard Deviation 14.701
|
18.50 mg/dL
Standard Deviation 7.951
|
15.92 mg/dL
Standard Deviation 8.246
|
15.96 mg/dL
Standard Deviation 8.466
|
13.87 mg/dL
Standard Deviation 6.107
|
15.83 mg/dL
Standard Deviation 8.726
|
16.54 mg/dL
Standard Deviation 7.863
|
15.26 mg/dL
Standard Deviation 5.056
|
19.39 mg/dL
Standard Deviation 8.322
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 127
|
19.32 mg/dL
Standard Deviation 9.534
|
21.59 mg/dL
Standard Deviation 7.992
|
19.72 mg/dL
Standard Deviation 8.091
|
17.91 mg/dL
Standard Deviation 11.445
|
17.38 mg/dL
Standard Deviation 12.631
|
20.48 mg/dL
Standard Deviation 11.594
|
23.21 mg/dL
Standard Deviation 14.231
|
16.61 mg/dL
Standard Deviation 7.686
|
21.61 mg/dL
Standard Deviation 13.121
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 141
|
19.16 mg/dL
Standard Deviation 9.573
|
23.68 mg/dL
Standard Deviation 9.564
|
19.52 mg/dL
Standard Deviation 10.627
|
17.61 mg/dL
Standard Deviation 7.518
|
18.54 mg/dL
Standard Deviation 9.913
|
18.13 mg/dL
Standard Deviation 7.279
|
22.25 mg/dL
Standard Deviation 15.109
|
17.39 mg/dL
Standard Deviation 5.007
|
20.09 mg/dL
Standard Deviation 9.409
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 155
|
20.56 mg/dL
Standard Deviation 9.319
|
21.41 mg/dL
Standard Deviation 7.028
|
19.30 mg/dL
Standard Deviation 9.632
|
16.17 mg/dL
Standard Deviation 8.144
|
18.92 mg/dL
Standard Deviation 10.738
|
17.00 mg/dL
Standard Deviation 3.905
|
22.21 mg/dL
Standard Deviation 11.858
|
16.52 mg/dL
Standard Deviation 7.141
|
18.57 mg/dL
Standard Deviation 9.110
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Baseline
|
21.42 mg/dL
Standard Deviation 6.858
|
22.48 mg/dL
Standard Deviation 7.869
|
17.44 mg/dL
Standard Deviation 7.509
|
17.66 mg/dL
Standard Deviation 9.090
|
16.63 mg/dL
Standard Deviation 6.273
|
19.92 mg/dL
Standard Deviation 9.312
|
23.79 mg/dL
Standard Deviation 11.286
|
20.92 mg/dL
Standard Deviation 7.651
|
17.50 mg/dL
Standard Deviation 8.549
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 5
|
23.85 mg/dL
Standard Deviation 10.657
|
21.95 mg/dL
Standard Deviation 8.249
|
19.80 mg/dL
Standard Deviation 11.927
|
16.08 mg/dL
Standard Deviation 8.356
|
18.00 mg/dL
Standard Deviation 10.065
|
21.36 mg/dL
Standard Deviation 9.999
|
19.70 mg/dL
Standard Deviation 8.249
|
17.22 mg/dL
Standard Deviation 5.977
|
20.68 mg/dL
Standard Deviation 10.035
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 15
|
23.04 mg/dL
Standard Deviation 9.035
|
22.68 mg/dL
Standard Deviation 9.712
|
18.52 mg/dL
Standard Deviation 9.265
|
16.28 mg/dL
Standard Deviation 8.735
|
16.25 mg/dL
Standard Deviation 10.605
|
17.20 mg/dL
Standard Deviation 8.921
|
20.42 mg/dL
Standard Deviation 9.930
|
16.50 mg/dL
Standard Deviation 9.869
|
20.43 mg/dL
Standard Deviation 10.612
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 57
|
20.88 mg/dL
Standard Deviation 7.957
|
21.55 mg/dL
Standard Deviation 5.878
|
15.44 mg/dL
Standard Deviation 5.108
|
16.83 mg/dL
Standard Deviation 12.437
|
13.54 mg/dL
Standard Deviation 4.222
|
14.36 mg/dL
Standard Deviation 6.034
|
17.46 mg/dL
Standard Deviation 8.939
|
13.87 mg/dL
Standard Deviation 4.674
|
20.13 mg/dL
Standard Deviation 10.092
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Day 169
|
19.60 mg/dL
Standard Deviation 7.286
|
24.55 mg/dL
Standard Deviation 11.931
|
19.13 mg/dL
Standard Deviation 8.644
|
23.00 mg/dL
Standard Deviation 23.279
|
18.00 mg/dL
Standard Deviation 10.167
|
18.88 mg/dL
Standard Deviation 7.732
|
21.42 mg/dL
Standard Deviation 7.442
|
17.30 mg/dL
Standard Deviation 6.292
|
19.68 mg/dL
Standard Deviation 8.306
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Change at Day 113
|
0.34 mg/dL
Standard Deviation 10.957
|
-3.98 mg/dL
Standard Deviation 8.873
|
-1.52 mg/dL
Standard Deviation 5.771
|
-0.76 mg/dL
Standard Deviation 9.276
|
-2.98 mg/dL
Standard Deviation 6.998
|
-4.29 mg/dL
Standard Deviation 8.538
|
-7.25 mg/dL
Standard Deviation 9.067
|
-5.35 mg/dL
Standard Deviation 6.619
|
1.89 mg/dL
Standard Deviation 5.762
|
|
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Change at Day 85
|
1.15 mg/dL
Standard Deviation 4.841
|
-2.70 mg/dL
Standard Deviation 7.069
|
-0.76 mg/dL
Standard Deviation 5.114
|
-2.63 mg/dL
Standard Deviation 9.497
|
-2.58 mg/dL
Standard Deviation 7.290
|
-5.68 mg/dL
Standard Deviation 6.973
|
-6.17 mg/dL
Standard Deviation 7.171
|
-6.57 mg/dL
Standard Deviation 6.726
|
-1.07 mg/dL
Standard Deviation 4.989
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Change at Day 113
|
-1.89 percent change
Standard Deviation 43.239
|
-10.80 percent change
Standard Deviation 38.288
|
-9.72 percent change
Standard Deviation 29.006
|
10.72 percent change
Standard Deviation 65.297
|
-10.36 percent change
Standard Deviation 36.732
|
-17.23 percent change
Standard Deviation 35.083
|
-26.62 percent change
Standard Deviation 28.464
|
-19.28 percent change
Standard Deviation 33.794
|
18.73 percent change
Standard Deviation 48.065
|
|
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Change at Day 85
|
7.08 percent change
Standard Deviation 26.054
|
-6.48 percent change
Standard Deviation 27.276
|
-7.61 percent change
Standard Deviation 23.163
|
5.66 percent change
Standard Deviation 76.931
|
-3.54 percent change
Standard Deviation 45.821
|
-23.42 percent change
Standard Deviation 30.458
|
-22.99 percent change
Standard Deviation 25.647
|
-28.96 percent change
Standard Deviation 25.281
|
-3.63 percent change
Standard Deviation 39.826
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Triglyceride (TG)
Day 57
|
139.50 mg/dL
Standard Deviation 56.099
|
137.55 mg/dL
Standard Deviation 53.502
|
102.28 mg/dL
Standard Deviation 33.512
|
117.21 mg/dL
Standard Deviation 84.666
|
90.67 mg/dL
Standard Deviation 28.925
|
94.40 mg/dL
Standard Deviation 49.048
|
124.25 mg/dL
Standard Deviation 69.357
|
92.52 mg/dL
Standard Deviation 45.106
|
136.78 mg/dL
Standard Deviation 67.987
|
|
Triglyceride (TG)
Day 71
|
156.27 mg/dL
Standard Deviation 65.687
|
139.27 mg/dL
Standard Deviation 85.017
|
122.68 mg/dL
Standard Deviation 52.192
|
112.13 mg/dL
Standard Deviation 56.034
|
103.13 mg/dL
Standard Deviation 47.534
|
103.13 mg/dL
Standard Deviation 51.243
|
125.50 mg/dL
Standard Deviation 74.428
|
93.91 mg/dL
Standard Deviation 39.340
|
146.43 mg/dL
Standard Deviation 64.368
|
|
Triglyceride (TG)
Day 99
|
156.84 mg/dL
Standard Deviation 70.931
|
137.82 mg/dL
Standard Deviation 60.866
|
122.96 mg/dL
Standard Deviation 55.697
|
118.17 mg/dL
Standard Deviation 63.727
|
115.08 mg/dL
Standard Deviation 63.629
|
110.56 mg/dL
Standard Deviation 57.944
|
128.25 mg/dL
Standard Deviation 70.840
|
131.32 mg/dL
Standard Deviation 118.340
|
133.91 mg/dL
Standard Deviation 49.879
|
|
Triglyceride (TG)
Day 106
|
131.68 mg/dL
Standard Deviation 55.816
|
133.41 mg/dL
Standard Deviation 68.902
|
116.16 mg/dL
Standard Deviation 55.618
|
109.91 mg/dL
Standard Deviation 45.304
|
93.54 mg/dL
Standard Deviation 38.520
|
97.80 mg/dL
Standard Deviation 46.662
|
116.29 mg/dL
Standard Deviation 50.480
|
102.59 mg/dL
Standard Deviation 50.880
|
139.00 mg/dL
Standard Deviation 53.142
|
|
Triglyceride (TG)
Day 113
|
141.64 mg/dL
Standard Deviation 96.032
|
129.14 mg/dL
Standard Deviation 73.031
|
111.72 mg/dL
Standard Deviation 53.875
|
116.26 mg/dL
Standard Deviation 69.771
|
101.43 mg/dL
Standard Deviation 52.274
|
101.58 mg/dL
Standard Deviation 51.130
|
112.88 mg/dL
Standard Deviation 60.824
|
94.39 mg/dL
Standard Deviation 34.093
|
136.61 mg/dL
Standard Deviation 64.291
|
|
Triglyceride (TG)
Day 127
|
133.40 mg/dL
Standard Deviation 66.304
|
153.14 mg/dL
Standard Deviation 62.304
|
138.08 mg/dL
Standard Deviation 60.533
|
139.83 mg/dL
Standard Deviation 103.182
|
124.50 mg/dL
Standard Deviation 86.402
|
133.40 mg/dL
Standard Deviation 71.046
|
159.25 mg/dL
Standard Deviation 101.582
|
115.96 mg/dL
Standard Deviation 63.954
|
159.43 mg/dL
Standard Deviation 89.130
|
|
Triglyceride (TG)
Day 141
|
131.08 mg/dL
Standard Deviation 56.266
|
156.27 mg/dL
Standard Deviation 76.965
|
135.80 mg/dL
Standard Deviation 75.159
|
119.91 mg/dL
Standard Deviation 59.343
|
129.13 mg/dL
Standard Deviation 70.190
|
115.13 mg/dL
Standard Deviation 51.964
|
164.79 mg/dL
Standard Deviation 129.257
|
123.39 mg/dL
Standard Deviation 35.150
|
137.35 mg/dL
Standard Deviation 56.775
|
|
Triglyceride (TG)
Day 155
|
139.44 mg/dL
Standard Deviation 65.901
|
149.23 mg/dL
Standard Deviation 68.510
|
129.00 mg/dL
Standard Deviation 70.010
|
119.91 mg/dL
Standard Deviation 61.088
|
133.33 mg/dL
Standard Deviation 81.100
|
115.44 mg/dL
Standard Deviation 39.459
|
164.13 mg/dL
Standard Deviation 102.919
|
113.83 mg/dL
Standard Deviation 43.209
|
131.74 mg/dL
Standard Deviation 62.736
|
|
Triglyceride (TG)
Day 169
|
149.40 mg/dL
Standard Deviation 58.176
|
167.91 mg/dL
Standard Deviation 79.436
|
126.67 mg/dL
Standard Deviation 60.290
|
166.22 mg/dL
Standard Deviation 176.973
|
128.26 mg/dL
Standard Deviation 71.260
|
120.76 mg/dL
Standard Deviation 56.962
|
151.63 mg/dL
Standard Deviation 59.252
|
122.43 mg/dL
Standard Deviation 65.091
|
125.41 mg/dL
Standard Deviation 36.439
|
|
Triglyceride (TG)
Baseline
|
140.23 mg/dL
Standard Deviation 51.283
|
152.59 mg/dL
Standard Deviation 50.105
|
122.40 mg/dL
Standard Deviation 50.578
|
124.40 mg/dL
Standard Deviation 59.717
|
111.58 mg/dL
Standard Deviation 42.354
|
121.04 mg/dL
Standard Deviation 56.152
|
158.21 mg/dL
Standard Deviation 71.477
|
127.65 mg/dL
Standard Deviation 59.878
|
130.39 mg/dL
Standard Deviation 49.826
|
|
Triglyceride (TG)
Day 8
|
150.40 mg/dL
Standard Deviation 76.908
|
128.43 mg/dL
Standard Deviation 50.155
|
122.72 mg/dL
Standard Deviation 66.459
|
103.50 mg/dL
Standard Deviation 48.515
|
130.91 mg/dL
Standard Deviation 75.156
|
126.44 mg/dL
Standard Deviation 123.041
|
124.58 mg/dL
Standard Deviation 49.786
|
95.71 mg/dL
Standard Deviation 42.796
|
136.91 mg/dL
Standard Deviation 91.378
|
|
Triglyceride (TG)
Day 15
|
149.31 mg/dL
Standard Deviation 64.392
|
145.91 mg/dL
Standard Deviation 79.420
|
125.64 mg/dL
Standard Deviation 55.667
|
113.52 mg/dL
Standard Deviation 60.601
|
114.25 mg/dL
Standard Deviation 54.003
|
109.52 mg/dL
Standard Deviation 65.672
|
143.96 mg/dL
Standard Deviation 70.871
|
123.96 mg/dL
Standard Deviation 108.066
|
130.65 mg/dL
Standard Deviation 53.724
|
|
Triglyceride (TG)
Day 22
|
133.65 mg/dL
Standard Deviation 48.535
|
144.64 mg/dL
Standard Deviation 68.531
|
125.00 mg/dL
Standard Deviation 54.636
|
109.04 mg/dL
Standard Deviation 49.088
|
113.79 mg/dL
Standard Deviation 106.198
|
105.56 mg/dL
Standard Deviation 45.283
|
119.17 mg/dL
Standard Deviation 55.800
|
101.96 mg/dL
Standard Deviation 54.725
|
130.26 mg/dL
Standard Deviation 59.246
|
|
Triglyceride (TG)
Day 29
|
147.92 mg/dL
Standard Deviation 68.536
|
130.00 mg/dL
Standard Deviation 52.743
|
111.24 mg/dL
Standard Deviation 46.683
|
142.84 mg/dL
Standard Deviation 141.763
|
94.29 mg/dL
Standard Deviation 37.698
|
97.84 mg/dL
Standard Deviation 49.164
|
133.38 mg/dL
Standard Deviation 74.370
|
100.04 mg/dL
Standard Deviation 39.343
|
122.09 mg/dL
Standard Deviation 49.749
|
|
Triglyceride (TG)
Day 36
|
154.65 mg/dL
Standard Deviation 59.929
|
139.95 mg/dL
Standard Deviation 79.796
|
115.12 mg/dL
Standard Deviation 54.424
|
109.17 mg/dL
Standard Deviation 54.052
|
105.67 mg/dL
Standard Deviation 38.421
|
113.68 mg/dL
Standard Deviation 71.769
|
111.25 mg/dL
Standard Deviation 45.529
|
96.52 mg/dL
Standard Deviation 56.535
|
158.30 mg/dL
Standard Deviation 102.642
|
|
Triglyceride (TG)
Day 43
|
159.19 mg/dL
Standard Deviation 85.270
|
135.23 mg/dL
Standard Deviation 70.762
|
123.80 mg/dL
Standard Deviation 52.925
|
119.44 mg/dL
Standard Deviation 53.110
|
109.29 mg/dL
Standard Deviation 54.365
|
108.16 mg/dL
Standard Deviation 56.609
|
161.75 mg/dL
Standard Deviation 134.409
|
130.71 mg/dL
Standard Deviation 124.380
|
140.61 mg/dL
Standard Deviation 73.706
|
|
Triglyceride (TG)
Day 50
|
148.50 mg/dL
Standard Deviation 77.558
|
121.64 mg/dL
Standard Deviation 51.406
|
123.48 mg/dL
Standard Deviation 61.199
|
114.22 mg/dL
Standard Deviation 53.090
|
113.29 mg/dL
Standard Deviation 53.870
|
108.12 mg/dL
Standard Deviation 65.442
|
126.58 mg/dL
Standard Deviation 56.883
|
100.57 mg/dL
Standard Deviation 52.553
|
142.30 mg/dL
Standard Deviation 83.014
|
|
Triglyceride (TG)
Day 85
|
142.81 mg/dL
Standard Deviation 57.891
|
142.45 mg/dL
Standard Deviation 60.126
|
118.64 mg/dL
Standard Deviation 46.593
|
100.04 mg/dL
Standard Deviation 53.185
|
99.92 mg/dL
Standard Deviation 40.798
|
92.36 mg/dL
Standard Deviation 47.872
|
130.25 mg/dL
Standard Deviation 78.800
|
95.00 mg/dL
Standard Deviation 54.102
|
119.17 mg/dL
Standard Deviation 57.046
|
|
Triglyceride (TG)
Day 5
|
154.27 mg/dL
Standard Deviation 74.707
|
146.41 mg/dL
Standard Deviation 76.274
|
128.20 mg/dL
Standard Deviation 79.256
|
115.40 mg/dL
Standard Deviation 52.401
|
114.25 mg/dL
Standard Deviation 61.969
|
134.20 mg/dL
Standard Deviation 78.692
|
130.30 mg/dL
Standard Deviation 58.718
|
112.17 mg/dL
Standard Deviation 47.884
|
121.09 mg/dL
Standard Deviation 48.602
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Change at Day 85
|
2.58 mg/dL
Standard Deviation 35.796
|
-10.14 mg/dL
Standard Deviation 43.129
|
-3.76 mg/dL
Standard Deviation 37.502
|
-15.87 mg/dL
Standard Deviation 48.341
|
-11.67 mg/dL
Standard Deviation 42.519
|
-28.68 mg/dL
Standard Deviation 41.898
|
-27.96 mg/dL
Standard Deviation 49.754
|
-29.52 mg/dL
Standard Deviation 40.669
|
-11.22 mg/dL
Standard Deviation 23.797
|
|
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Change at Day 113
|
-0.58 mg/dL
Standard Deviation 63.896
|
-23.45 mg/dL
Standard Deviation 51.443
|
-10.68 mg/dL
Standard Deviation 27.488
|
0.35 mg/dL
Standard Deviation 48.858
|
-12.46 mg/dL
Standard Deviation 44.128
|
-20.02 mg/dL
Standard Deviation 41.197
|
-45.33 mg/dL
Standard Deviation 53.285
|
-30.13 mg/dL
Standard Deviation 48.592
|
6.22 mg/dL
Standard Deviation 32.888
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Change at Day 85
|
3.74 percent change
Standard Deviation 27.803
|
-5.20 percent change
Standard Deviation 23.919
|
2.62 percent change
Standard Deviation 33.715
|
-9.40 percent change
Standard Deviation 42.868
|
-5.21 percent change
Standard Deviation 35.698
|
-21.00 percent change
Standard Deviation 31.109
|
-16.85 percent change
Standard Deviation 28.672
|
-23.38 percent change
Standard Deviation 24.421
|
-9.33 percent change
Standard Deviation 19.235
|
|
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Change at Day 113
|
-3.82 percent change
Standard Deviation 36.247
|
-15.23 percent change
Standard Deviation 24.917
|
-8.31 percent change
Standard Deviation 19.500
|
1.32 percent change
Standard Deviation 37.694
|
-8.47 percent change
Standard Deviation 35.865
|
-14.44 percent change
Standard Deviation 26.916
|
-27.65 percent change
Standard Deviation 26.827
|
-17.70 percent change
Standard Deviation 29.263
|
4.57 percent change
Standard Deviation 29.077
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Baseline
|
163.90 mg/dL
Standard Deviation 25.271
|
165.86 mg/dL
Standard Deviation 26.655
|
188.72 mg/dL
Standard Deviation 30.222
|
182.86 mg/dL
Standard Deviation 22.842
|
182.17 mg/dL
Standard Deviation 21.217
|
159.58 mg/dL
Standard Deviation 29.033
|
155.54 mg/dL
Standard Deviation 20.706
|
154.71 mg/dL
Standard Deviation 22.511
|
181.17 mg/dL
Standard Deviation 23.577
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 5
|
161.23 mg/dL
Standard Deviation 22.059
|
140.77 mg/dL
Standard Deviation 26.324
|
154.36 mg/dL
Standard Deviation 35.666
|
143.24 mg/dL
Standard Deviation 23.520
|
137.50 mg/dL
Standard Deviation 28.770
|
113.52 mg/dL
Standard Deviation 28.259
|
97.78 mg/dL
Standard Deviation 25.034
|
98.48 mg/dL
Standard Deviation 15.003
|
189.36 mg/dL
Standard Deviation 24.432
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 8
|
162.16 mg/dL
Standard Deviation 29.067
|
131.52 mg/dL
Standard Deviation 23.712
|
142.84 mg/dL
Standard Deviation 36.478
|
123.25 mg/dL
Standard Deviation 25.378
|
122.73 mg/dL
Standard Deviation 29.183
|
93.24 mg/dL
Standard Deviation 22.966
|
79.33 mg/dL
Standard Deviation 27.140
|
76.17 mg/dL
Standard Deviation 15.222
|
193.70 mg/dL
Standard Deviation 20.424
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 15
|
162.35 mg/dL
Standard Deviation 20.558
|
130.27 mg/dL
Standard Deviation 19.489
|
138.40 mg/dL
Standard Deviation 38.794
|
103.16 mg/dL
Standard Deviation 26.742
|
99.13 mg/dL
Standard Deviation 22.099
|
95.68 mg/dL
Standard Deviation 27.248
|
77.88 mg/dL
Standard Deviation 27.299
|
57.96 mg/dL
Standard Deviation 16.134
|
191.61 mg/dL
Standard Deviation 22.845
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 22
|
160.04 mg/dL
Standard Deviation 19.838
|
130.59 mg/dL
Standard Deviation 24.595
|
115.36 mg/dL
Standard Deviation 37.861
|
88.71 mg/dL
Standard Deviation 24.172
|
88.29 mg/dL
Standard Deviation 28.964
|
69.92 mg/dL
Standard Deviation 23.315
|
58.92 mg/dL
Standard Deviation 23.638
|
48.26 mg/dL
Standard Deviation 10.037
|
192.09 mg/dL
Standard Deviation 18.757
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 50
|
157.62 mg/dL
Standard Deviation 22.608
|
130.64 mg/dL
Standard Deviation 25.964
|
101.60 mg/dL
Standard Deviation 36.427
|
80.30 mg/dL
Standard Deviation 20.448
|
78.96 mg/dL
Standard Deviation 27.207
|
59.92 mg/dL
Standard Deviation 17.814
|
52.58 mg/dL
Standard Deviation 21.847
|
45.65 mg/dL
Standard Deviation 11.276
|
186.70 mg/dL
Standard Deviation 20.220
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 57
|
153.15 mg/dL
Standard Deviation 19.601
|
126.68 mg/dL
Standard Deviation 28.919
|
101.80 mg/dL
Standard Deviation 35.249
|
86.08 mg/dL
Standard Deviation 30.679
|
73.21 mg/dL
Standard Deviation 24.568
|
75.76 mg/dL
Standard Deviation 23.552
|
58.13 mg/dL
Standard Deviation 23.709
|
44.26 mg/dL
Standard Deviation 9.186
|
180.17 mg/dL
Standard Deviation 17.167
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 71
|
161.54 mg/dL
Standard Deviation 22.089
|
134.91 mg/dL
Standard Deviation 30.239
|
115.48 mg/dL
Standard Deviation 36.001
|
82.25 mg/dL
Standard Deviation 22.283
|
76.13 mg/dL
Standard Deviation 22.793
|
81.83 mg/dL
Standard Deviation 28.164
|
58.08 mg/dL
Standard Deviation 26.357
|
48.65 mg/dL
Standard Deviation 13.110
|
185.96 mg/dL
Standard Deviation 28.798
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 99
|
156.36 mg/dL
Standard Deviation 18.830
|
133.68 mg/dL
Standard Deviation 34.790
|
118.36 mg/dL
Standard Deviation 32.875
|
85.29 mg/dL
Standard Deviation 30.599
|
74.50 mg/dL
Standard Deviation 19.496
|
88.56 mg/dL
Standard Deviation 28.234
|
66.04 mg/dL
Standard Deviation 29.895
|
60.05 mg/dL
Standard Deviation 35.754
|
190.52 mg/dL
Standard Deviation 20.551
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 106
|
154.08 mg/dL
Standard Deviation 19.378
|
130.82 mg/dL
Standard Deviation 29.301
|
107.76 mg/dL
Standard Deviation 31.232
|
77.87 mg/dL
Standard Deviation 23.470
|
74.75 mg/dL
Standard Deviation 22.115
|
64.04 mg/dL
Standard Deviation 24.315
|
51.50 mg/dL
Standard Deviation 23.178
|
54.14 mg/dL
Standard Deviation 28.648
|
183.35 mg/dL
Standard Deviation 19.664
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 113
|
146.36 mg/dL
Standard Deviation 23.787
|
131.41 mg/dL
Standard Deviation 32.515
|
111.80 mg/dL
Standard Deviation 30.993
|
83.00 mg/dL
Standard Deviation 27.632
|
72.35 mg/dL
Standard Deviation 20.232
|
82.50 mg/dL
Standard Deviation 24.128
|
63.54 mg/dL
Standard Deviation 25.086
|
55.78 mg/dL
Standard Deviation 27.153
|
180.65 mg/dL
Standard Deviation 16.489
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 127
|
158.60 mg/dL
Standard Deviation 22.504
|
163.36 mg/dL
Standard Deviation 33.835
|
164.60 mg/dL
Standard Deviation 38.791
|
113.13 mg/dL
Standard Deviation 46.332
|
102.75 mg/dL
Standard Deviation 33.666
|
134.80 mg/dL
Standard Deviation 24.100
|
117.42 mg/dL
Standard Deviation 37.408
|
85.09 mg/dL
Standard Deviation 41.318
|
191.78 mg/dL
Standard Deviation 28.623
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 155
|
161.80 mg/dL
Standard Deviation 21.960
|
169.41 mg/dL
Standard Deviation 37.377
|
190.96 mg/dL
Standard Deviation 34.453
|
164.83 mg/dL
Standard Deviation 34.193
|
144.58 mg/dL
Standard Deviation 40.902
|
149.60 mg/dL
Standard Deviation 26.876
|
144.83 mg/dL
Standard Deviation 26.836
|
133.30 mg/dL
Standard Deviation 30.526
|
184.48 mg/dL
Standard Deviation 18.030
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 169
|
159.12 mg/dL
Standard Deviation 20.961
|
174.45 mg/dL
Standard Deviation 41.877
|
193.88 mg/dL
Standard Deviation 33.789
|
183.52 mg/dL
Standard Deviation 37.346
|
162.65 mg/dL
Standard Deviation 40.341
|
155.48 mg/dL
Standard Deviation 28.791
|
153.75 mg/dL
Standard Deviation 25.535
|
148.52 mg/dL
Standard Deviation 27.770
|
193.59 mg/dL
Standard Deviation 17.816
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 29
|
159.16 mg/dL
Standard Deviation 20.163
|
133.41 mg/dL
Standard Deviation 30.589
|
115.52 mg/dL
Standard Deviation 38.434
|
90.68 mg/dL
Standard Deviation 25.610
|
82.46 mg/dL
Standard Deviation 20.659
|
81.08 mg/dL
Standard Deviation 26.644
|
71.79 mg/dL
Standard Deviation 26.662
|
51.09 mg/dL
Standard Deviation 14.820
|
192.59 mg/dL
Standard Deviation 23.425
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 36
|
159.46 mg/dL
Standard Deviation 25.221
|
129.32 mg/dL
Standard Deviation 29.451
|
103.72 mg/dL
Standard Deviation 37.651
|
81.83 mg/dL
Standard Deviation 15.898
|
79.42 mg/dL
Standard Deviation 26.345
|
66.20 mg/dL
Standard Deviation 21.848
|
53.38 mg/dL
Standard Deviation 22.329
|
44.96 mg/dL
Standard Deviation 10.598
|
184.74 mg/dL
Standard Deviation 25.913
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 43
|
157.31 mg/dL
Standard Deviation 16.790
|
132.05 mg/dL
Standard Deviation 29.005
|
112.60 mg/dL
Standard Deviation 37.446
|
88.16 mg/dL
Standard Deviation 23.005
|
82.08 mg/dL
Standard Deviation 27.547
|
79.64 mg/dL
Standard Deviation 23.937
|
66.63 mg/dL
Standard Deviation 30.685
|
51.46 mg/dL
Standard Deviation 14.926
|
194.30 mg/dL
Standard Deviation 22.876
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 141
|
155.52 mg/dL
Standard Deviation 20.490
|
170.41 mg/dL
Standard Deviation 37.185
|
187.96 mg/dL
Standard Deviation 41.528
|
154.17 mg/dL
Standard Deviation 45.140
|
128.96 mg/dL
Standard Deviation 44.304
|
149.17 mg/dL
Standard Deviation 29.556
|
142.08 mg/dL
Standard Deviation 32.188
|
119.83 mg/dL
Standard Deviation 42.083
|
191.09 mg/dL
Standard Deviation 24.978
|
|
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Day 85
|
154.92 mg/dL
Standard Deviation 22.289
|
139.05 mg/dL
Standard Deviation 36.247
|
110.40 mg/dL
Standard Deviation 30.783
|
78.00 mg/dL
Standard Deviation 27.144
|
72.17 mg/dL
Standard Deviation 18.874
|
77.28 mg/dL
Standard Deviation 25.268
|
60.04 mg/dL
Standard Deviation 23.665
|
49.87 mg/dL
Standard Deviation 24.464
|
175.17 mg/dL
Standard Deviation 24.398
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Change at Day 85
|
-8.98 mg/dL
Standard Deviation 20.888
|
-26.82 mg/dL
Standard Deviation 28.796
|
-78.32 mg/dL
Standard Deviation 33.436
|
-104.26 mg/dL
Standard Deviation 34.056
|
-110.00 mg/dL
Standard Deviation 24.274
|
-82.30 mg/dL
Standard Deviation 30.323
|
-95.50 mg/dL
Standard Deviation 32.345
|
-104.07 mg/dL
Standard Deviation 27.573
|
-6.00 mg/dL
Standard Deviation 24.009
|
|
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Change at Day 113
|
-18.40 mg/dL
Standard Deviation 22.784
|
-34.45 mg/dL
Standard Deviation 26.242
|
-76.92 mg/dL
Standard Deviation 35.588
|
-99.26 mg/dL
Standard Deviation 27.347
|
-111.33 mg/dL
Standard Deviation 24.646
|
-77.33 mg/dL
Standard Deviation 22.371
|
-92.00 mg/dL
Standard Deviation 32.099
|
-98.15 mg/dL
Standard Deviation 28.798
|
-0.52 mg/dL
Standard Deviation 20.267
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Change at Day 85
|
-4.77 percent change
Standard Deviation 11.716
|
-16.20 percent change
Standard Deviation 16.334
|
-41.11 percent change
Standard Deviation 16.193
|
-56.87 percent change
Standard Deviation 14.745
|
-60.17 percent change
Standard Deviation 10.493
|
-50.98 percent change
Standard Deviation 15.662
|
-60.62 percent change
Standard Deviation 17.746
|
-67.69 percent change
Standard Deviation 14.462
|
-2.49 percent change
Standard Deviation 12.951
|
|
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Change at Day 113
|
-10.59 percent change
Standard Deviation 11.977
|
-20.67 percent change
Standard Deviation 15.155
|
-40.19 percent change
Standard Deviation 17.244
|
-54.54 percent change
Standard Deviation 13.671
|
-60.43 percent change
Standard Deviation 11.070
|
-48.56 percent change
Standard Deviation 12.284
|
-58.57 percent change
Standard Deviation 17.970
|
-63.92 percent change
Standard Deviation 15.872
|
0.88 percent change
Standard Deviation 13.236
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 141
|
3.7508 ratio
Standard Deviation 0.88092
|
3.9841 ratio
Standard Deviation 0.87530
|
4.4256 ratio
Standard Deviation 1.20555
|
3.6070 ratio
Standard Deviation 1.06034
|
3.3500 ratio
Standard Deviation 1.37776
|
3.5433 ratio
Standard Deviation 0.67339
|
3.5242 ratio
Standard Deviation 0.96281
|
3.0078 ratio
Standard Deviation 0.91134
|
4.2843 ratio
Standard Deviation 1.17378
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 155
|
3.9100 ratio
Standard Deviation 0.92453
|
3.9205 ratio
Standard Deviation 0.79163
|
4.5057 ratio
Standard Deviation 1.18175
|
3.8126 ratio
Standard Deviation 0.99748
|
3.6450 ratio
Standard Deviation 1.45582
|
3.6240 ratio
Standard Deviation 0.63587
|
3.6392 ratio
Standard Deviation 0.92468
|
3.2748 ratio
Standard Deviation 0.76307
|
4.1804 ratio
Standard Deviation 1.03516
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 169
|
3.7436 ratio
Standard Deviation 0.86236
|
4.0036 ratio
Standard Deviation 0.99761
|
4.4975 ratio
Standard Deviation 1.25117
|
4.2000 ratio
Standard Deviation 1.23292
|
3.8970 ratio
Standard Deviation 1.40230
|
3.8140 ratio
Standard Deviation 0.77275
|
3.7471 ratio
Standard Deviation 0.82852
|
3.4830 ratio
Standard Deviation 0.67010
|
4.1182 ratio
Standard Deviation 0.81436
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 5
|
3.9465 ratio
Standard Deviation 0.83527
|
3.5668 ratio
Standard Deviation 0.77085
|
3.9264 ratio
Standard Deviation 1.11497
|
3.5036 ratio
Standard Deviation 0.76250
|
3.4029 ratio
Standard Deviation 0.86267
|
3.1372 ratio
Standard Deviation 0.81529
|
2.7861 ratio
Standard Deviation 0.57451
|
2.7500 ratio
Standard Deviation 0.38981
|
4.3259 ratio
Standard Deviation 0.99932
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 8
|
3.8588 ratio
Standard Deviation 0.92894
|
3.3510 ratio
Standard Deviation 0.79979
|
3.6024 ratio
Standard Deviation 1.07004
|
3.1367 ratio
Standard Deviation 0.80233
|
3.0941 ratio
Standard Deviation 0.80907
|
2.7252 ratio
Standard Deviation 0.63762
|
2.4100 ratio
Standard Deviation 0.53023
|
2.3083 ratio
Standard Deviation 0.33483
|
4.3374 ratio
Standard Deviation 0.88617
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 15
|
3.9308 ratio
Standard Deviation 0.89274
|
3.2700 ratio
Standard Deviation 0.68229
|
3.4940 ratio
Standard Deviation 1.02033
|
2.7772 ratio
Standard Deviation 0.71059
|
2.6050 ratio
Standard Deviation 0.53948
|
2.6884 ratio
Standard Deviation 0.58429
|
2.3754 ratio
Standard Deviation 0.62550
|
1.9658 ratio
Standard Deviation 0.33815
|
4.3017 ratio
Standard Deviation 0.84316
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 22
|
3.8915 ratio
Standard Deviation 0.75155
|
3.2550 ratio
Standard Deviation 0.66627
|
3.0676 ratio
Standard Deviation 0.92151
|
2.4338 ratio
Standard Deviation 0.43218
|
2.3617 ratio
Standard Deviation 0.35946
|
2.2428 ratio
Standard Deviation 0.53640
|
2.0258 ratio
Standard Deviation 0.49301
|
1.7730 ratio
Standard Deviation 0.18504
|
4.2822 ratio
Standard Deviation 0.97569
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 29
|
3.8852 ratio
Standard Deviation 0.73498
|
3.3318 ratio
Standard Deviation 0.70099
|
3.0260 ratio
Standard Deviation 0.77510
|
2.5780 ratio
Standard Deviation 0.75738
|
2.2800 ratio
Standard Deviation 0.37240
|
2.4020 ratio
Standard Deviation 0.54386
|
2.2533 ratio
Standard Deviation 0.64125
|
1.8296 ratio
Standard Deviation 0.26896
|
4.1023 ratio
Standard Deviation 0.81890
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 36
|
3.9496 ratio
Standard Deviation 0.92977
|
3.2882 ratio
Standard Deviation 0.68375
|
2.8452 ratio
Standard Deviation 0.78785
|
2.3000 ratio
Standard Deviation 0.31095
|
2.2529 ratio
Standard Deviation 0.39114
|
2.1924 ratio
Standard Deviation 0.45842
|
1.9300 ratio
Standard Deviation 0.46830
|
1.7404 ratio
Standard Deviation 0.18627
|
4.2222 ratio
Standard Deviation 0.97022
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 43
|
3.9338 ratio
Standard Deviation 0.87409
|
3.3259 ratio
Standard Deviation 0.70739
|
3.0044 ratio
Standard Deviation 0.77172
|
2.5124 ratio
Standard Deviation 0.80082
|
2.3004 ratio
Standard Deviation 0.42044
|
2.3688 ratio
Standard Deviation 0.48338
|
2.1396 ratio
Standard Deviation 0.61972
|
1.8754 ratio
Standard Deviation 0.39255
|
4.4074 ratio
Standard Deviation 1.03394
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 50
|
3.9419 ratio
Standard Deviation 0.98670
|
3.3277 ratio
Standard Deviation 0.71213
|
2.8300 ratio
Standard Deviation 0.81738
|
2.2883 ratio
Standard Deviation 0.38697
|
2.2658 ratio
Standard Deviation 0.43915
|
2.0280 ratio
Standard Deviation 0.36876
|
1.9254 ratio
Standard Deviation 0.48864
|
1.7443 ratio
Standard Deviation 0.15406
|
4.2909 ratio
Standard Deviation 0.97014
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 57
|
3.9596 ratio
Standard Deviation 0.84943
|
3.2632 ratio
Standard Deviation 0.60608
|
2.8436 ratio
Standard Deviation 0.67094
|
2.5708 ratio
Standard Deviation 1.24941
|
2.2225 ratio
Standard Deviation 0.37721
|
2.3148 ratio
Standard Deviation 0.44657
|
2.0758 ratio
Standard Deviation 0.63508
|
1.7448 ratio
Standard Deviation 0.12638
|
4.3361 ratio
Standard Deviation 0.97295
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 71
|
4.0085 ratio
Standard Deviation 0.93120
|
3.3855 ratio
Standard Deviation 0.64850
|
3.0528 ratio
Standard Deviation 0.77095
|
2.3258 ratio
Standard Deviation 0.34951
|
2.1988 ratio
Standard Deviation 0.36789
|
2.3925 ratio
Standard Deviation 0.57023
|
1.9988 ratio
Standard Deviation 0.56686
|
1.7709 ratio
Standard Deviation 0.19489
|
4.3791 ratio
Standard Deviation 1.15180
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 85
|
4.0508 ratio
Standard Deviation 0.91154
|
3.3986 ratio
Standard Deviation 0.73940
|
3.1204 ratio
Standard Deviation 0.72628
|
2.2796 ratio
Standard Deviation 0.46691
|
2.2142 ratio
Standard Deviation 0.37394
|
2.3724 ratio
Standard Deviation 0.52972
|
2.0721 ratio
Standard Deviation 0.54913
|
1.8561 ratio
Standard Deviation 0.49386
|
4.2613 ratio
Standard Deviation 1.08945
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 99
|
3.7648 ratio
Standard Deviation 0.83515
|
3.3073 ratio
Standard Deviation 0.81497
|
3.0868 ratio
Standard Deviation 0.75654
|
2.4075 ratio
Standard Deviation 0.70042
|
2.2121 ratio
Standard Deviation 0.37358
|
2.4564 ratio
Standard Deviation 0.54658
|
2.1417 ratio
Standard Deviation 0.70783
|
2.0305 ratio
Standard Deviation 0.76914
|
4.4200 ratio
Standard Deviation 1.15874
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 106
|
3.7912 ratio
Standard Deviation 0.78337
|
3.2832 ratio
Standard Deviation 0.72097
|
2.9176 ratio
Standard Deviation 0.75101
|
2.2517 ratio
Standard Deviation 0.37291
|
2.1896 ratio
Standard Deviation 0.37808
|
2.0476 ratio
Standard Deviation 0.40004
|
1.8650 ratio
Standard Deviation 0.50620
|
1.8814 ratio
Standard Deviation 0.56847
|
4.3157 ratio
Standard Deviation 1.01377
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 127
|
3.7984 ratio
Standard Deviation 0.90030
|
3.9132 ratio
Standard Deviation 0.79683
|
3.9896 ratio
Standard Deviation 0.99046
|
2.9087 ratio
Standard Deviation 0.92317
|
2.8208 ratio
Standard Deviation 1.08222
|
3.3776 ratio
Standard Deviation 0.67839
|
3.1533 ratio
Standard Deviation 0.98795
|
2.4822 ratio
Standard Deviation 0.91213
|
4.4717 ratio
Standard Deviation 1.06069
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Baseline
|
3.9629 ratio
Standard Deviation 0.77435
|
4.0223 ratio
Standard Deviation 0.81145
|
4.5408 ratio
Standard Deviation 1.11809
|
4.2558 ratio
Standard Deviation 1.15512
|
4.2610 ratio
Standard Deviation 1.08481
|
4.0118 ratio
Standard Deviation 0.82813
|
4.0154 ratio
Standard Deviation 0.92478
|
3.8500 ratio
Standard Deviation 0.72414
|
4.1076 ratio
Standard Deviation 0.88524
|
|
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Day 113
|
3.8248 ratio
Standard Deviation 0.91875
|
3.2359 ratio
Standard Deviation 0.65683
|
3.0760 ratio
Standard Deviation 0.78321
|
2.3639 ratio
Standard Deviation 0.45213
|
2.2335 ratio
Standard Deviation 0.42128
|
2.4688 ratio
Standard Deviation 0.50001
|
2.1042 ratio
Standard Deviation 0.55015
|
1.9691 ratio
Standard Deviation 0.52016
|
4.3570 ratio
Standard Deviation 0.88681
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Change at Day 85
|
0.0879 ratio
Standard Deviation 0.43755
|
-0.6236 ratio
Standard Deviation 0.66072
|
-1.4204 ratio
Standard Deviation 0.91892
|
-1.8407 ratio
Standard Deviation 0.85260
|
-2.0469 ratio
Standard Deviation 0.96230
|
-1.6394 ratio
Standard Deviation 0.69058
|
-1.9433 ratio
Standard Deviation 0.90358
|
-1.9835 ratio
Standard Deviation 0.78766
|
0.1537 ratio
Standard Deviation 0.47755
|
|
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Change at Day 113
|
-0.1560 ratio
Standard Deviation 0.53286
|
-0.7864 ratio
Standard Deviation 0.60966
|
-1.4648 ratio
Standard Deviation 0.83864
|
-1.7563 ratio
Standard Deviation 0.74752
|
-2.0461 ratio
Standard Deviation 0.92038
|
-1.5671 ratio
Standard Deviation 0.65875
|
-1.9113 ratio
Standard Deviation 0.93385
|
-1.8704 ratio
Standard Deviation 0.73630
|
0.2493 ratio
Standard Deviation 0.43772
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Change at Day 85
|
2.19 percent change
Standard Deviation 10.328
|
-14.65 percent change
Standard Deviation 14.740
|
-29.51 percent change
Standard Deviation 16.200
|
-43.25 percent change
Standard Deviation 12.569
|
-45.74 percent change
Standard Deviation 11.961
|
-39.99 percent change
Standard Deviation 12.892
|
-47.06 percent change
Standard Deviation 15.152
|
-50.43 percent change
Standard Deviation 13.358
|
3.81 percent change
Standard Deviation 10.643
|
|
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Change at Day 113
|
-3.81 percent change
Standard Deviation 12.537
|
-18.57 percent change
Standard Deviation 13.541
|
-31.07 percent change
Standard Deviation 14.770
|
-41.49 percent change
Standard Deviation 10.520
|
-45.65 percent change
Standard Deviation 12.114
|
-38.20 percent change
Standard Deviation 10.463
|
-46.04 percent change
Standard Deviation 15.705
|
-47.68 percent change
Standard Deviation 13.195
|
6.98 percent change
Standard Deviation 12.436
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Baseline
|
0.6687 ratio
Standard Deviation 0.12269
|
0.6775 ratio
Standard Deviation 0.14076
|
0.7890 ratio
Standard Deviation 0.17841
|
0.7324 ratio
Standard Deviation 0.16556
|
0.7167 ratio
Standard Deviation 0.16058
|
0.6846 ratio
Standard Deviation 0.14145
|
0.6606 ratio
Standard Deviation 0.13665
|
0.6567 ratio
Standard Deviation 0.12772
|
0.6980 ratio
Standard Deviation 0.13867
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 5
|
0.6612 ratio
Standard Deviation 0.12682
|
0.5968 ratio
Standard Deviation 0.14211
|
0.6428 ratio
Standard Deviation 0.18885
|
0.5792 ratio
Standard Deviation 0.11372
|
0.5300 ratio
Standard Deviation 0.11967
|
0.4896 ratio
Standard Deviation 0.14794
|
0.4135 ratio
Standard Deviation 0.11264
|
0.4222 ratio
Standard Deviation 0.07116
|
0.7100 ratio
Standard Deviation 0.12642
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 8
|
0.6660 ratio
Standard Deviation 0.14947
|
0.5657 ratio
Standard Deviation 0.14552
|
0.5844 ratio
Standard Deviation 0.18410
|
0.5017 ratio
Standard Deviation 0.12310
|
0.4718 ratio
Standard Deviation 0.13900
|
0.4044 ratio
Standard Deviation 0.09862
|
0.3363 ratio
Standard Deviation 0.11305
|
0.3271 ratio
Standard Deviation 0.06760
|
0.7230 ratio
Standard Deviation 0.11227
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 15
|
0.6712 ratio
Standard Deviation 0.13137
|
0.5445 ratio
Standard Deviation 0.11164
|
0.5776 ratio
Standard Deviation 0.16885
|
0.4216 ratio
Standard Deviation 0.11929
|
0.3763 ratio
Standard Deviation 0.08293
|
0.4308 ratio
Standard Deviation 0.12426
|
0.3300 ratio
Standard Deviation 0.12322
|
0.2450 ratio
Standard Deviation 0.05649
|
0.7226 ratio
Standard Deviation 0.13404
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 22
|
0.6773 ratio
Standard Deviation 0.13012
|
0.5564 ratio
Standard Deviation 0.13347
|
0.4868 ratio
Standard Deviation 0.17148
|
0.3629 ratio
Standard Deviation 0.10897
|
0.3283 ratio
Standard Deviation 0.09220
|
0.3136 ratio
Standard Deviation 0.10610
|
0.2463 ratio
Standard Deviation 0.09668
|
0.2078 ratio
Standard Deviation 0.04572
|
0.7248 ratio
Standard Deviation 0.12409
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 29
|
0.6776 ratio
Standard Deviation 0.12337
|
0.5609 ratio
Standard Deviation 0.11924
|
0.4820 ratio
Standard Deviation 0.14437
|
0.3720 ratio
Standard Deviation 0.11247
|
0.3254 ratio
Standard Deviation 0.07524
|
0.3656 ratio
Standard Deviation 0.12076
|
0.3058 ratio
Standard Deviation 0.12721
|
0.2196 ratio
Standard Deviation 0.05943
|
0.7023 ratio
Standard Deviation 0.11439
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 36
|
0.6873 ratio
Standard Deviation 0.15278
|
0.5600 ratio
Standard Deviation 0.13551
|
0.4428 ratio
Standard Deviation 0.15255
|
0.3250 ratio
Standard Deviation 0.06093
|
0.3050 ratio
Standard Deviation 0.08900
|
0.2900 ratio
Standard Deviation 0.09278
|
0.2421 ratio
Standard Deviation 0.10206
|
0.1983 ratio
Standard Deviation 0.04376
|
0.7048 ratio
Standard Deviation 0.13413
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 43
|
0.6788 ratio
Standard Deviation 0.12944
|
0.5805 ratio
Standard Deviation 0.11978
|
0.4696 ratio
Standard Deviation 0.15115
|
0.3632 ratio
Standard Deviation 0.14522
|
0.3188 ratio
Standard Deviation 0.09124
|
0.3592 ratio
Standard Deviation 0.10723
|
0.2800 ratio
Standard Deviation 0.12399
|
0.2142 ratio
Standard Deviation 0.05012
|
0.7548 ratio
Standard Deviation 0.16351
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 50
|
0.6804 ratio
Standard Deviation 0.13489
|
0.5959 ratio
Standard Deviation 0.13893
|
0.4472 ratio
Standard Deviation 0.16198
|
0.3283 ratio
Standard Deviation 0.08917
|
0.3133 ratio
Standard Deviation 0.09234
|
0.2668 ratio
Standard Deviation 0.07669
|
0.2313 ratio
Standard Deviation 0.10182
|
0.2048 ratio
Standard Deviation 0.04088
|
0.7465 ratio
Standard Deviation 0.13878
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 57
|
0.6938 ratio
Standard Deviation 0.12747
|
0.5682 ratio
Standard Deviation 0.13297
|
0.4616 ratio
Standard Deviation 0.15220
|
0.3804 ratio
Standard Deviation 0.18286
|
0.3196 ratio
Standard Deviation 0.07765
|
0.3584 ratio
Standard Deviation 0.09715
|
0.2642 ratio
Standard Deviation 0.13319
|
0.2026 ratio
Standard Deviation 0.04081
|
0.7630 ratio
Standard Deviation 0.13394
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 71
|
0.6958 ratio
Standard Deviation 0.13840
|
0.5986 ratio
Standard Deviation 0.12434
|
0.4976 ratio
Standard Deviation 0.15592
|
0.3358 ratio
Standard Deviation 0.07678
|
0.3146 ratio
Standard Deviation 0.08086
|
0.3692 ratio
Standard Deviation 0.12402
|
0.2592 ratio
Standard Deviation 0.11602
|
0.2157 ratio
Standard Deviation 0.05281
|
0.7500 ratio
Standard Deviation 0.17328
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 85
|
0.7023 ratio
Standard Deviation 0.13946
|
0.6132 ratio
Standard Deviation 0.16069
|
0.5264 ratio
Standard Deviation 0.14405
|
0.3435 ratio
Standard Deviation 0.11007
|
0.3125 ratio
Standard Deviation 0.08125
|
0.3768 ratio
Standard Deviation 0.11546
|
0.2696 ratio
Standard Deviation 0.11705
|
0.2335 ratio
Standard Deviation 0.10170
|
0.7665 ratio
Standard Deviation 0.18376
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 99
|
0.6584 ratio
Standard Deviation 0.13120
|
0.5882 ratio
Standard Deviation 0.15930
|
0.5164 ratio
Standard Deviation 0.15168
|
0.3650 ratio
Standard Deviation 0.15223
|
0.3075 ratio
Standard Deviation 0.07170
|
0.3928 ratio
Standard Deviation 0.12458
|
0.2904 ratio
Standard Deviation 0.12791
|
0.2491 ratio
Standard Deviation 0.12432
|
0.7883 ratio
Standard Deviation 0.18622
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 106
|
0.6716 ratio
Standard Deviation 0.12925
|
0.5877 ratio
Standard Deviation 0.15253
|
0.4796 ratio
Standard Deviation 0.14386
|
0.3322 ratio
Standard Deviation 0.09130
|
0.3142 ratio
Standard Deviation 0.08230
|
0.2908 ratio
Standard Deviation 0.08450
|
0.2267 ratio
Standard Deviation 0.10925
|
0.2405 ratio
Standard Deviation 0.12187
|
0.7730 ratio
Standard Deviation 0.14455
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 113
|
0.6556 ratio
Standard Deviation 0.14192
|
0.5777 ratio
Standard Deviation 0.12976
|
0.5140 ratio
Standard Deviation 0.15398
|
0.3557 ratio
Standard Deviation 0.10710
|
0.3235 ratio
Standard Deviation 0.08804
|
0.3888 ratio
Standard Deviation 0.10343
|
0.2908 ratio
Standard Deviation 0.11858
|
0.2548 ratio
Standard Deviation 0.10845
|
0.7683 ratio
Standard Deviation 0.14272
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 127
|
0.6692 ratio
Standard Deviation 0.13546
|
0.6950 ratio
Standard Deviation 0.15732
|
0.7024 ratio
Standard Deviation 0.18033
|
0.4730 ratio
Standard Deviation 0.18425
|
0.4325 ratio
Standard Deviation 0.16469
|
0.5772 ratio
Standard Deviation 0.11473
|
0.5029 ratio
Standard Deviation 0.17571
|
0.3778 ratio
Standard Deviation 0.19064
|
0.7830 ratio
Standard Deviation 0.15893
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 141
|
0.6580 ratio
Standard Deviation 0.13916
|
0.7082 ratio
Standard Deviation 0.17595
|
0.7916 ratio
Standard Deviation 0.20262
|
0.6352 ratio
Standard Deviation 0.20727
|
0.5375 ratio
Standard Deviation 0.23022
|
0.6233 ratio
Standard Deviation 0.12107
|
0.5938 ratio
Standard Deviation 0.15786
|
0.5004 ratio
Standard Deviation 0.19354
|
0.7570 ratio
Standard Deviation 0.17219
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 155
|
0.6664 ratio
Standard Deviation 0.13225
|
0.6991 ratio
Standard Deviation 0.17124
|
0.8148 ratio
Standard Deviation 0.20102
|
0.6839 ratio
Standard Deviation 0.19315
|
0.6075 ratio
Standard Deviation 0.24120
|
0.6368 ratio
Standard Deviation 0.11957
|
0.6125 ratio
Standard Deviation 0.15224
|
0.5574 ratio
Standard Deviation 0.13288
|
0.7452 ratio
Standard Deviation 0.16318
|
|
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Day 169
|
0.6424 ratio
Standard Deviation 0.14621
|
0.6845 ratio
Standard Deviation 0.17986
|
0.8088 ratio
Standard Deviation 0.20105
|
0.7178 ratio
Standard Deviation 0.18178
|
0.6639 ratio
Standard Deviation 0.22661
|
0.6640 ratio
Standard Deviation 0.14350
|
0.6321 ratio
Standard Deviation 0.14774
|
0.6161 ratio
Standard Deviation 0.12493
|
0.7359 ratio
Standard Deviation 0.13397
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Change at Day 85
|
0.0337 ratio
Standard Deviation 0.09054
|
-0.0643 ratio
Standard Deviation 0.11318
|
-0.2626 ratio
Standard Deviation 0.16341
|
-0.3748 ratio
Standard Deviation 0.17224
|
-0.4042 ratio
Standard Deviation 0.14894
|
-0.3078 ratio
Standard Deviation 0.13144
|
-0.3910 ratio
Standard Deviation 0.15635
|
-0.4211 ratio
Standard Deviation 0.16147
|
0.0685 ratio
Standard Deviation 0.10818
|
|
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Change at Day 113
|
-0.0170 ratio
Standard Deviation 0.10303
|
-0.0998 ratio
Standard Deviation 0.09487
|
-0.2750 ratio
Standard Deviation 0.15604
|
-0.3626 ratio
Standard Deviation 0.14553
|
-0.3965 ratio
Standard Deviation 0.15431
|
-0.2998 ratio
Standard Deviation 0.12105
|
-0.3698 ratio
Standard Deviation 0.16194
|
-0.3998 ratio
Standard Deviation 0.15163
|
0.0702 ratio
Standard Deviation 0.09306
|
SECONDARY outcome
Timeframe: Baseline, Day 85, 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Change at Day 85
|
5.51 percent change
Standard Deviation 12.823
|
-9.13 percent change
Standard Deviation 16.695
|
-32.09 percent change
Standard Deviation 18.463
|
-50.97 percent change
Standard Deviation 16.380
|
-55.16 percent change
Standard Deviation 11.927
|
-44.37 percent change
Standard Deviation 16.358
|
-58.47 percent change
Standard Deviation 19.271
|
-63.09 percent change
Standard Deviation 16.240
|
10.41 percent change
Standard Deviation 15.319
|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Change at Day 113
|
-2.03 percent change
Standard Deviation 14.326
|
-14.00 percent change
Standard Deviation 14.205
|
-34.11 percent change
Standard Deviation 18.505
|
-49.84 percent change
Standard Deviation 13.744
|
-53.65 percent change
Standard Deviation 13.386
|
-43.21 percent change
Standard Deviation 13.147
|
-55.05 percent change
Standard Deviation 19.756
|
-60.32 percent change
Standard Deviation 15.924
|
11.47 percent change
Standard Deviation 16.250
|
SECONDARY outcome
Timeframe: Baseline up to Day 113Population: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. The outcome measure was planned to be analyzed for all the reporting groups except Atorvastatin + Ezetimibe 10 mg.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=25 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C <10 mg/dL
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C <25 mg/dL
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
20.8 percentage of participants
|
0.0 percentage of participants
|
12.0 percentage of participants
|
66.7 percentage of participants
|
58.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C <40 mg/dL
|
0.0 percentage of participants
|
12.0 percentage of participants
|
36.0 percentage of participants
|
41.7 percentage of participants
|
0.0 percentage of participants
|
84.0 percentage of participants
|
91.7 percentage of participants
|
95.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C <100 mg/dL
|
23.1 percentage of participants
|
92.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
4.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C <70 mg/dL
|
0.0 percentage of participants
|
64.0 percentage of participants
|
92.0 percentage of participants
|
87.5 percentage of participants
|
0.0 percentage of participants
|
96.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=22 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
SAEs
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
AEs
|
13 participants
|
5 participants
|
16 participants
|
16 participants
|
15 participants
|
17 participants
|
16 participants
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.
Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=6.23 for PF-04950615 were considered ADA positive.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=25 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody (ADA) Response
|
—
|
13 participants
|
16 participants
|
11 participants
|
—
|
14 participants
|
6 participants
|
14 participants
|
—
|
SECONDARY outcome
Timeframe: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The pharmacokinetic (PK) parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=12 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=12 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=13 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Single dose
|
32.97 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 42
|
51.49 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 46
|
82.05 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 45
|
—
|
—
|
32.98 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 57
|
52.33 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 49
|
77.11 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 43
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Multiple dose
|
63.74 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 57
|
136.6 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 32
|
273.5 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 100
|
—
|
—
|
63.54 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 40
|
92.46 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 127
|
242.5 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 81
|
—
|
SECONDARY outcome
Timeframe: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=9 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=7 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=10 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=7 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
|
111.7 mcg*day/mL
Geometric Coefficient of Variation 63
|
237.4 mcg*day/mL
Geometric Coefficient of Variation 41
|
248.4 mcg*day/mL
Geometric Coefficient of Variation 76
|
—
|
—
|
94.83 mcg*day/mL
Geometric Coefficient of Variation 46
|
176.9 mcg*day/mL
Geometric Coefficient of Variation 144
|
469.5 mcg*day/mL
Geometric Coefficient of Variation 90
|
—
|
SECONDARY outcome
Timeframe: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=10 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=12 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=10 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
|
96.32 mcg*day/mL
Geometric Coefficient of Variation 65
|
220.9 mcg*day/mL
Geometric Coefficient of Variation 39
|
486.7 mcg*day/mL
Geometric Coefficient of Variation 143
|
—
|
—
|
87.86 mcg*day/mL
Geometric Coefficient of Variation 49
|
140.3 mcg*day/mL
Geometric Coefficient of Variation 145
|
434.2 mcg*day/mL
Geometric Coefficient of Variation 91
|
—
|
SECONDARY outcome
Timeframe: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=12 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=12 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=13 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Single dose
|
2.994 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 44
|
4.744 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
7.726 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
3.173 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 61
|
5.074 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 50
|
7.382 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Multiple dose
|
5.874 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 55
|
12.22 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
23.64 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 88
|
—
|
—
|
6.197 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
8.343 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 119
|
21.91 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 76
|
—
|
SECONDARY outcome
Timeframe: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=10 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=12 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=10 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615
|
2.858 mcg/mL
Geometric Coefficient of Variation 64
|
6.571 mcg/mL
Geometric Coefficient of Variation 40
|
13.47 mcg/mL
Geometric Coefficient of Variation 139
|
—
|
—
|
2.176 mcg/mL
Geometric Coefficient of Variation 65
|
4.041 mcg/mL
Geometric Coefficient of Variation 147
|
12.95 mcg/mL
Geometric Coefficient of Variation 94
|
—
|
SECONDARY outcome
Timeframe: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=12 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=12 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=12 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=13 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Single dose
|
5.94 day
Interval 3.94 to 6.95
|
5.45 day
Interval 2.95 to 6.94
|
6.94 day
Interval 2.96 to 14.0
|
—
|
—
|
4.01 day
Interval 3.0 to 5.96
|
4.97 day
Interval 3.94 to 7.0
|
5.94 day
Interval 1.94 to 7.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Multiple dose
|
2.99 day
Interval 0.985 to 7.06
|
2.98 day
Interval 0.988 to 4.98
|
4.98 day
Interval 2.97 to 7.0
|
—
|
—
|
3.03 day
Interval 2.92 to 6.98
|
2.98 day
Interval 1.0 to 4.97
|
2.97 day
Interval 0.964 to 4.99
|
—
|
SECONDARY outcome
Timeframe: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)Population: The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=9 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=11 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=7 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=10 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=7 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=8 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of PF-04950615
|
9.404 day
Standard Deviation 2.1454
|
9.570 day
Standard Deviation 2.2338
|
9.333 day
Standard Deviation 2.7535
|
—
|
—
|
7.716 day
Standard Deviation 1.7594
|
9.471 day
Standard Deviation 2.2889
|
10.56 day
Standard Deviation 1.5934
|
—
|
SECONDARY outcome
Timeframe: Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141Population: PK concentration population included participants in FAS who have at least 1 concentration of either PF-04950615, PCSK9 or atorvastatin or its active metabolites. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter \[ng/mL\]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Atorvastatin + PF-04950615 Placebo
n=26 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg
n=25 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 50 mg
n=25 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=23 Participants
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
Atorvastatin + PF-04950615 50 mg
n=25 Participants
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 Participants
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
PF-04950615 Placebo
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 1
|
269.19 ng/mL
Standard Deviation 66.8377
|
228.80 ng/mL
Standard Deviation 49.9983
|
215.50 ng/mL
Standard Deviation 43.0086
|
234.42 ng/mL
Standard Deviation 77.5410
|
210.22 ng/mL
Standard Deviation 48.5536
|
266.64 ng/mL
Standard Deviation 61.5494
|
261.23 ng/mL
Standard Deviation 72.3625
|
285.96 ng/mL
Standard Deviation 75.7940
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 5
|
291.77 ng/mL
Standard Deviation 65.8011
|
1952.5 ng/mL
Standard Deviation 527.661
|
1775.4 ng/mL
Standard Deviation 531.225
|
1712.0 ng/mL
Standard Deviation 458.574
|
240.41 ng/mL
Standard Deviation 63.093
|
2292.2 ng/mL
Standard Deviation 676.414
|
2152.6 ng/mL
Standard Deviation 451.749
|
1997.7 ng/mL
Standard Deviation 563.722
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 8
|
292.19 ng/mL
Standard Deviation 62.5108
|
2490.4 ng/mL
Standard Deviation 573.777
|
2297.7 ng/mL
Standard Deviation 521.003
|
2306.7 ng/mL
Standard Deviation 594.409
|
240.22 ng/mL
Standard Deviation 53.5842
|
2711.2 ng/mL
Standard Deviation 614.649
|
2701.9 ng/mL
Standard Deviation 568.958
|
2539.5 ng/mL
Standard Deviation 587.196
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 15
|
303.42 ng/mL
Standard Deviation 47.9418
|
2590.6 ng/mL
Standard Deviation 601.052
|
3030.8 ng/mL
Standard Deviation 715.193
|
2966.7 ng/mL
Standard Deviation 713.934
|
224.43 ng/mL
Standard Deviation 57.6903
|
2539.8 ng/mL
Standard Deviation 558.369
|
3198.1 ng/mL
Standard Deviation 897.565
|
3291.9 ng/mL
Standard Deviation 624.935
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 22
|
295 ng/mL
Standard Deviation 71.6996
|
3117.4 ng/mL
Standard Deviation 582.258
|
2971.6 ng/mL
Standard Deviation 669.215
|
2726.7 ng/mL
Standard Deviation 616.409
|
218.82 ng/mL
Standard Deviation 41.2647
|
3451.7 ng/mL
Standard Deviation 872.597
|
3297.3 ng/mL
Standard Deviation 701.137
|
3166.5 ng/mL
Standard Deviation 663.295
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 29
|
275 ng/mL
Standard Deviation 57.6888
|
3050.0 ng/mL
Standard Deviation 534.176
|
3095.5 ng/mL
Standard Deviation 647.481
|
2955.6 ng/mL
Standard Deviation 678.703
|
230.09 ng/mL
Standard Deviation 44.1742
|
2844.2 ng/mL
Standard Deviation 684.693
|
3224.8 ng/mL
Standard Deviation 868.760
|
3419.8 ng/mL
Standard Deviation 715.001
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 36
|
304.75 ng/mL
Standard Deviation 48.529
|
3237.0 ng/mL
Standard Deviation 694.727
|
3011.2 ng/mL
Standard Deviation 578.469
|
2761.4 ng/mL
Standard Deviation 601.567
|
233.09 ng/mL
Standard Deviation 56.7693
|
3446.2 ng/mL
Standard Deviation 825.704
|
3310.7 ng/mL
Standard Deviation 732.706
|
3248.5 ng/mL
Standard Deviation 660.213
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 43
|
303.54 ng/mL
Standard Deviation 81.0823
|
3278.9 ng/mL
Standard Deviation 693.207
|
3302.5 ng/mL
Standard Deviation 584.658
|
3016.9 ng/mL
Standard Deviation 772.615
|
239.13 ng/mL
Standard Deviation 43.8782
|
2900.9 ng/mL
Standard Deviation 653.572
|
3406.3 ng/mL
Standard Deviation 765.437
|
3391.9 ng/mL
Standard Deviation 717.922
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 50
|
293.38 ng/mL
Standard Deviation 66.9138
|
3148.5 ng/mL
Standard Deviation 541.230
|
3001.3 ng/mL
Standard Deviation 696.256
|
2820.3 ng/mL
Standard Deviation 693.130
|
237.40 ng/mL
Standard Deviation 68.2421
|
3394.8 ng/mL
Standard Deviation 750.557
|
3297.2 ng/mL
Standard Deviation 654.384
|
3230.9 ng/mL
Standard Deviation 716.416
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 57
|
277.69 ng/mL
Standard Deviation 70.6132
|
2910.6 ng/mL
Standard Deviation 531.493
|
3026.4 ng/mL
Standard Deviation 708.490
|
2791.9 ng/mL
Standard Deviation 633.717
|
220.13 ng/mL
Standard Deviation 66.99
|
2779.2 ng/mL
Standard Deviation 698.727
|
3204.8 ng/mL
Standard Deviation 699.490
|
3390.6 ng/mL
Standard Deviation 1149.17
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 71
|
285.81 ng/mL
Standard Deviation 45.5315
|
3066.8 ng/mL
Standard Deviation 693.445
|
3197.1 ng/mL
Standard Deviation 575.162
|
2887.6 ng/mL
Standard Deviation 684.734
|
355.17 ng/mL
Standard Deviation 556.079
|
2889.6 ng/mL
Standard Deviation 542.831
|
3241.2 ng/mL
Standard Deviation 724.363
|
3280.5 ng/mL
Standard Deviation 727.932
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 85
|
276.31 ng/mL
Standard Deviation 72.3396
|
2898.7 ng/mL
Standard Deviation 551.114
|
2934.1 ng/mL
Standard Deviation 548.311
|
2787.9 ng/mL
Standard Deviation 812.792
|
269.61 ng/mL
Standard Deviation 201.161
|
2727.0 ng/mL
Standard Deviation 635.595
|
3166.3 ng/mL
Standard Deviation 736.216
|
3198.9 ng/mL
Standard Deviation 827.313
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 99
|
326.08 ng/mL
Standard Deviation 78.8759
|
3119.2 ng/mL
Standard Deviation 665.408
|
3149.3 ng/mL
Standard Deviation 590.228
|
2918.9 ng/mL
Standard Deviation 752.647
|
252.13 ng/mL
Standard Deviation 72.1011
|
2915.1 ng/mL
Standard Deviation 711.932
|
3242.9 ng/mL
Standard Deviation 684.758
|
3259.6 ng/mL
Standard Deviation 754.730
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 106
|
283.67 ng/mL
Standard Deviation 58.9079
|
3165.7 ng/mL
Standard Deviation 786.665
|
2755.7 ng/mL
Standard Deviation 549.755
|
2566.5 ng/mL
Standard Deviation 483.133
|
242.23 ng/mL
Standard Deviation 59.4266
|
3326.7 ng/mL
Standard Deviation 611.790
|
3138.9 ng/mL
Standard Deviation 604.177
|
2864.0 ng/mL
Standard Deviation 596.757
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 113
|
267.71 ng/mL
Standard Deviation 68.1498
|
2908.4 ng/mL
Standard Deviation 639.771
|
3009.8 ng/mL
Standard Deviation 685.462
|
2683.9 ng/mL
Standard Deviation 574.842
|
222.05 ng/mL
Standard Deviation 46.0574
|
2727.3 ng/mL
Standard Deviation 710.746
|
2919.0 ng/mL
Standard Deviation 511.959
|
2910.3 ng/mL
Standard Deviation 609.380
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 127
|
281.40 ng/mL
Standard Deviation 95.7562
|
1778.9 ng/mL
Standard Deviation 872.368
|
2556.0 ng/mL
Standard Deviation 772.015
|
2769.7 ng/mL
Standard Deviation 736.453
|
249.87 ng/mL
Standard Deviation 63.2113
|
1429.8 ng/mL
Standard Deviation 599.406
|
2148.7 ng/mL
Standard Deviation 1062.32
|
3030.7 ng/mL
Standard Deviation 607.610
|
—
|
|
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Day 141
|
290.16 ng/mL
Standard Deviation 84.2168
|
1056.5 ng/mL
Standard Deviation 545.337
|
1477.0 ng/mL
Standard Deviation 816.342
|
2368.7 ng/mL
Standard Deviation 1106.62
|
20.043 ng/mL
Standard Deviation 68.7012
|
736.63 ng/mL
Standard Deviation 297.087
|
1382.8 ng/mL
Standard Deviation 892.457
|
2851.0 ng/mL
Standard Deviation 1373.69
|
—
|
Adverse Events
Atorvastatin + PF-04950615 50 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Atorvastatin + PF-04950615 100 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Atorvastatin + PF-04950615 150 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Atorvastatin + PF-04950615 Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Atorvastatin + Ezetimibe 10 mg QD PO
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-04950615 50 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-04950615 100 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-04950615 150 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-04950615 Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin + PF-04950615 50 mg
n=25 participants at risk
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 Placebo
n=26 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg QD PO
n=22 participants at risk
Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open).
|
PF-04950615 50 mg
n=25 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 Placebo
n=23 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/23
|
Other adverse events
| Measure |
Atorvastatin + PF-04950615 50 mg
n=25 participants at risk
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to \[\>=\]100 milligram per deciliter \[mg/dL\]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 100 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 150 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + PF-04950615 Placebo
n=26 participants at risk
Participants with fasting LDL-C level (\>=100 \[mg/dL\]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
|
Atorvastatin + Ezetimibe 10 mg QD PO
n=22 participants at risk
Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open).
|
PF-04950615 50 mg
n=25 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 100 mg
n=25 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 150 mg
n=24 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
|
PF-04950615 Placebo
n=23 participants at risk
Participants with fasting LDL-C level (\>=130 \[mg/dL\]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
8.0%
2/25
|
25.0%
6/24
|
33.3%
8/24
|
0.00%
0/26
|
0.00%
0/22
|
16.0%
4/25
|
28.0%
7/25
|
25.0%
6/24
|
4.3%
1/23
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/25
|
0.00%
0/24
|
4.2%
1/24
|
7.7%
2/26
|
0.00%
0/22
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Injection site pain
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
12.5%
3/24
|
0.00%
0/23
|
|
General disorders
Injection site pruritus
|
8.0%
2/25
|
16.7%
4/24
|
29.2%
7/24
|
0.00%
0/26
|
0.00%
0/22
|
16.0%
4/25
|
24.0%
6/25
|
20.8%
5/24
|
0.00%
0/23
|
|
General disorders
Injection site swelling
|
0.00%
0/25
|
0.00%
0/24
|
8.3%
2/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
5/25
|
4.2%
1/24
|
4.2%
1/24
|
19.2%
5/26
|
4.5%
1/22
|
12.0%
3/25
|
16.0%
4/25
|
8.3%
2/24
|
17.4%
4/23
|
|
Infections and infestations
Pharyngitis
|
4.0%
1/25
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
20.8%
5/24
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
8.7%
2/23
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25
|
4.2%
1/24
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/22
|
0.00%
0/25
|
12.0%
3/25
|
0.00%
0/24
|
4.3%
1/23
|
|
Investigations
Blood alkaline phosphatase increased
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
8.3%
2/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
7.7%
2/26
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25
|
4.2%
1/24
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/22
|
12.0%
3/25
|
0.00%
0/25
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
0.00%
0/24
|
8.3%
2/24
|
0.00%
0/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
4.0%
1/25
|
8.3%
2/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/25
|
4.2%
1/24
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.0%
2/25
|
12.5%
3/24
|
0.00%
0/24
|
7.7%
2/26
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
4.5%
1/22
|
12.0%
3/25
|
0.00%
0/25
|
0.00%
0/24
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25
|
8.3%
2/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/17
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/15
|
0.00%
0/13
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER