Trial Outcomes & Findings for A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin (NCT NCT00530946)
NCT ID: NCT00530946
Last Updated: 2021-01-28
Results Overview
Value at Week 8 minus value at baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
165 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-01-28
Participant Flow
Twenty (20) centers in Japan
A total of 301 subjects entered the 6-week diet observation period and the end of diet observation period, 165 subjects who met all the inclusion criteria for the treatment period and had no conflict to exclusion criteria were randomized to 4 CI-1038 groups.
Participant milestones
| Measure |
CI-1038 2.5 mg/5 mg
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
41
|
40
|
|
Overall Study
COMPLETED
|
41
|
39
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
CI-1038 2.5 mg/5 mg
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Noncompliance
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Baseline characteristics by cohort
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<20 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Age, Customized
20 to 44 years
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Age, Customized
45 to 64 years
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
23 participants
n=5 Participants
|
23 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
14 participants
n=5 Participants
|
12 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
41 participants
n=5 Participants
|
40 participants
n=4 Participants
|
165 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Value at Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-16.6 mm Hg
Standard Error 1.65
|
-15.9 mm Hg
Standard Error 1.69
|
-21.8 mm Hg
Standard Error 1.69
|
-18.9 mm Hg
Standard Error 1.71
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Percent of "value at Week 8 minus value at baseline" over value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Percent Change in Low Density Lipoprotein-Cholesterol
|
-37.2 Percent Change
Standard Error 1.49
|
-42.5 Percent Change
Standard Error 1.52
|
-34.3 Percent Change
Standard Error 1.52
|
-40.6 Percent Change
Standard Error 1.54
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 8 weeksPopulation: Full Analysis Set, Observed Cases
Value at Week 2, Week 4, or Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Each Observation Point
Week 2
|
-12.8 mm Hg
Standard Deviation 9.63
|
-13.5 mm Hg
Standard Deviation 10.18
|
-19.2 mm Hg
Standard Deviation 10.53
|
-16.0 mm Hg
Standard Deviation 9.01
|
|
Change in Systolic Blood Pressure From Baseline to Each Observation Point
Week 4
|
-14.2 mm Hg
Standard Deviation 10.26
|
-14.6 mm Hg
Standard Deviation 12.33
|
-20.2 mm Hg
Standard Deviation 11.08
|
-19.6 mm Hg
Standard Deviation 11.03
|
|
Change in Systolic Blood Pressure From Baseline to Each Observation Point
Week 8
|
-16.8 mm Hg
Standard Deviation 11.40
|
-15.3 mm Hg
Standard Deviation 11.59
|
-21.3 mm Hg
Standard Deviation 10.07
|
-18.7 mm Hg
Standard Deviation 11.24
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Value at Week 2, Week 4, or Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Week 2
|
-4.9 mm Hg
Standard Deviation 6.23
|
-6.0 mm Hg
Standard Deviation 6.05
|
-8.1 mm Hg
Standard Deviation 6.24
|
-8.2 mm Hg
Standard Deviation 6.38
|
|
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Week 4
|
-5.3 mm Hg
Standard Deviation 4.96
|
-8.2 mm Hg
Standard Deviation 7.13
|
-9.4 mm Hg
Standard Deviation 6.19
|
-9.2 mm Hg
Standard Deviation 6.62
|
|
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Week 8
|
-7.7 mm Hg
Standard Deviation 6.34
|
-8.7 mm Hg
Standard Deviation 8.06
|
-12.0 mm Hg
Standard Deviation 6.31
|
-9.9 mm Hg
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 2
|
-34.8 Percent Change
Standard Deviation 9.11
|
-42.5 Percent Change
Standard Deviation 11.00
|
-32.8 Percent Change
Standard Deviation 9.15
|
-40.2 Percent Change
Standard Deviation 13.52
|
|
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 4
|
-37.4 Percent Change
Standard Deviation 7.67
|
-43.8 Percent Change
Standard Deviation 9.30
|
-35.0 Percent Change
Standard Deviation 9.19
|
-41.8 Percent Change
Standard Deviation 9.53
|
|
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 8
|
-37.6 Percent Change
Standard Deviation 7.80
|
-42.9 Percent Change
Standard Deviation 10.28
|
-34.2 Percent Change
Standard Deviation 9.22
|
-40.8 Percent Change
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Week 2
|
-24.2 Percent Change
Standard Deviation 6.86
|
-30.5 Percent Change
Standard Deviation 8.44
|
-23.0 Percent Change
Standard Deviation 7.22
|
-28.3 Percent Change
Standard Deviation 10.04
|
|
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Week 4
|
-26.6 Percent Change
Standard Deviation 6.36
|
-31.5 Percent Change
Standard Deviation 7.08
|
-24.7 Percent Change
Standard Deviation 7.64
|
-28.6 Percent Change
Standard Deviation 7.44
|
|
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Week 8
|
-26.1 Percent Change
Standard Deviation 6.01
|
-30.0 Percent Change
Standard Deviation 8.43
|
-23.4 Percent Change
Standard Deviation 7.78
|
-28.2 Percent Change
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 2
|
7.7 Percent Change
Standard Deviation 12.11
|
8.3 Percent Change
Standard Deviation 10.70
|
6.6 Percent Change
Standard Deviation 9.12
|
9.9 Percent Change
Standard Deviation 10.32
|
|
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 4
|
7.2 Percent Change
Standard Deviation 8.16
|
7.9 Percent Change
Standard Deviation 13.03
|
9.3 Percent Change
Standard Deviation 13.24
|
11.9 Percent Change
Standard Deviation 13.28
|
|
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Week 8
|
7.2 Percent Change
Standard Deviation 10.86
|
7.5 Percent Change
Standard Deviation 13.27
|
9.7 Percent Change
Standard Deviation 10.59
|
10.8 Percent Change
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Each Observation Point
Week 2
|
-15.1 Percent Change
Standard Deviation 33.82
|
-27.4 Percent Change
Standard Deviation 22.48
|
-16.2 Percent Change
Standard Deviation 20.00
|
-23.9 Percent Change
Standard Deviation 24.51
|
|
Percent Change in Triglycerides From Baseline to Each Observation Point
Week 4
|
-14.2 Percent Change
Standard Deviation 25.31
|
-25.7 Percent Change
Standard Deviation 18.15
|
-15.1 Percent Change
Standard Deviation 22.42
|
-23.2 Percent Change
Standard Deviation 28.55
|
|
Percent Change in Triglycerides From Baseline to Each Observation Point
Week 8
|
-14.1 Percent Change
Standard Deviation 19.72
|
-21.1 Percent Change
Standard Deviation 21.68
|
-10.8 Percent Change
Standard Deviation 31.42
|
-24.0 Percent Change
Standard Deviation 25.15
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 8 weeksPopulation: Full Analysis Set, Observed Cases
Value at Week 2, Week 4, or Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Week 2
|
-1.2 Ratio
Standard Deviation 0.58
|
-1.4 Ratio
Standard Deviation 0.42
|
-1.1 Ratio
Standard Deviation 0.49
|
-1.3 Ratio
Standard Deviation 0.53
|
|
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Week 4
|
-1.3 Ratio
Standard Deviation 0.41
|
-1.4 Ratio
Standard Deviation 0.42
|
-1.2 Ratio
Standard Deviation 0.56
|
-1.4 Ratio
Standard Deviation 0.49
|
|
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Week 8
|
-1.2 Ratio
Standard Deviation 0.37
|
-1.4 Ratio
Standard Deviation 0.44
|
-1.2 Ratio
Standard Deviation 0.52
|
-1.4 Ratio
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks , and 8 weeksPopulation: Full Analysis Set, Observed Cases
Value at Week 2, Week 4, or Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Week 2
|
-1.3 Ratio
Standard Deviation 0.71
|
-1.6 Ratio
Standard Deviation 0.49
|
-1.2 Ratio
Standard Deviation 0.61
|
-1.5 Ratio
Standard Deviation 0.64
|
|
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Week 4
|
-1.4 Ratio
Standard Deviation 0.48
|
-1.6 Ratio
Standard Deviation 0.49
|
-1.4 Ratio
Standard Deviation 0.69
|
-1.6 Ratio
Standard Deviation 0.59
|
|
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Week 8
|
-1.3 Ratio
Standard Deviation 0.43
|
-1.5 Ratio
Standard Deviation 0.51
|
-1.4 Ratio
Standard Deviation 0.65
|
-1.5 Ratio
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 8 weeksPopulation: Full Analysis Set, Observed Cases
Value at Week 2, Week 4, or Week 8 minus value at baseline
Outcome measures
| Measure |
CI-1038 2.5 mg/5 mg
n=43 Participants
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 Participants
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 Participants
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 Participants
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Change in Apolipoprotein B From Baseline to Each Observation Point
Week 2
|
-36.6 mg/dL
Standard Deviation 12.55
|
-45.8 mg/dL
Standard Deviation 12.11
|
-33.5 mg/dL
Standard Deviation 9.86
|
-44.4 mg/dL
Standard Deviation 15.46
|
|
Change in Apolipoprotein B From Baseline to Each Observation Point
Week 4
|
-40.1 mg/dL
Standard Deviation 10.94
|
-47.2 mg/dL
Standard Deviation 10.20
|
-36.6 mg/dL
Standard Deviation 11.36
|
-45.8 mg/dL
Standard Deviation 13.79
|
|
Change in Apolipoprotein B From Baseline to Each Observation Point
Week 8
|
-40.2 mg/dL
Standard Deviation 9.65
|
-46.4 mg/dL
Standard Deviation 10.87
|
-36.6 mg/dL
Standard Deviation 12.27
|
-45.1 mg/dL
Standard Deviation 14.39
|
Adverse Events
CI-1038 2.5 mg/5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CI-1038 2.5 mg/10 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CI-1038 5 mg/5 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CI-1038 5 mg/10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CI-1038 2.5 mg/5 mg
n=43 participants at risk
Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
|
CI-1038 2.5 mg/10 mg
n=41 participants at risk
Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
|
CI-1038 5 mg/5 mg
n=41 participants at risk
Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
|
CI-1038 5 mg/10 mg
n=40 participants at risk
Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/41
|
0.00%
0/40
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/43
|
0.00%
0/41
|
4.9%
2/41
|
0.00%
0/40
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
6/43
|
7.3%
3/41
|
12.2%
5/41
|
17.5%
7/40
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/43
|
4.9%
2/41
|
2.4%
1/41
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/41
|
2.5%
1/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER