Trial Outcomes & Findings for Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk (NCT NCT01953328)
NCT ID: NCT01953328
Last Updated: 2015-12-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
409 participants
Primary outcome timeframe
Baseline and Weeks 10 and 12
Results posted on
2015-12-23
Participant Flow
Japanese men and women ≥ 20 to ≤ 85 years of age, with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (2.6 mmol/L), fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L), and at high risk for cardiovascular events were eligible to participate. First patient enrolled on 07 October 2013 and last patient enrolled on 17 February 2014.
409 participants were randomized to 1 of 2 open-label atorvastatin cohorts (5 mg or 20 mg) for the lipid stabilization period; 404 were then randomized to blinded investigational product. Both randomizations were stratified by heterozygous familial hypercholesterolemia (HeFH) diagnosis and lipid-lowering therapy.
Participant milestones
| Measure |
A5 Placebo Q2W
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
50
|
50
|
52
|
51
|
51
|
51
|
|
Overall Study
Received Treatment
|
49
|
50
|
50
|
50
|
52
|
51
|
51
|
51
|
|
Overall Study
COMPLETED
|
49
|
50
|
50
|
50
|
50
|
51
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
A5 Placebo Q2W
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
Baseline characteristics by cohort
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
60.4 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
60.4 years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
60.1 years
STANDARD_DEVIATION 9.9 • n=115 Participants
|
61.8 years
STANDARD_DEVIATION 11.9 • n=6 Participants
|
61.3 years
STANDARD_DEVIATION 10.3 • n=6 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
160 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
244 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
50 participants
n=5 Participants
|
50 participants
n=4 Participants
|
52 participants
n=21 Participants
|
51 participants
n=10 Participants
|
51 participants
n=115 Participants
|
51 participants
n=6 Participants
|
404 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
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
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
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
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Stratification Factor
Diagnosis of HeFH
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=6 Participants
|
21 participants
n=6 Participants
|
|
Stratification Factor
Non-HeFH and Intensive Statin Use
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
11 participants
n=10 Participants
|
11 participants
n=115 Participants
|
11 participants
n=6 Participants
|
85 participants
n=6 Participants
|
|
Stratification Factor
Non-HeFH and Non-Intensive Statin Use
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
37 participants
n=5 Participants
|
37 participants
n=4 Participants
|
38 participants
n=21 Participants
|
38 participants
n=10 Participants
|
37 participants
n=115 Participants
|
37 participants
n=6 Participants
|
298 participants
n=6 Participants
|
|
LDL-C Concentration
|
115.7 mg/dL
STANDARD_DEVIATION 26.0 • n=5 Participants
|
114.0 mg/dL
STANDARD_DEVIATION 29.2 • n=7 Participants
|
121.9 mg/dL
STANDARD_DEVIATION 44.6 • n=5 Participants
|
118.8 mg/dL
STANDARD_DEVIATION 36.6 • n=4 Participants
|
90.9 mg/dL
STANDARD_DEVIATION 25.5 • n=21 Participants
|
90.7 mg/dL
STANDARD_DEVIATION 20.8 • n=10 Participants
|
95.8 mg/dL
STANDARD_DEVIATION 23.6 • n=115 Participants
|
98.0 mg/dL
STANDARD_DEVIATION 25.6 • n=6 Participants
|
105.5 mg/dL
STANDARD_DEVIATION 32.0 • n=6 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
142.0 mg/dL
STANDARD_DEVIATION 30.4 • n=5 Participants
|
141.2 mg/dL
STANDARD_DEVIATION 31.8 • n=7 Participants
|
151.8 mg/dL
STANDARD_DEVIATION 48.8 • n=5 Participants
|
147.8 mg/dL
STANDARD_DEVIATION 39.6 • n=4 Participants
|
118.2 mg/dL
STANDARD_DEVIATION 28.6 • n=21 Participants
|
117.5 mg/dL
STANDARD_DEVIATION 25.1 • n=10 Participants
|
121.8 mg/dL
STANDARD_DEVIATION 29.8 • n=115 Participants
|
122.7 mg/dL
STANDARD_DEVIATION 29.5 • n=6 Participants
|
132.7 mg/dL
STANDARD_DEVIATION 35.9 • n=6 Participants
|
|
Apolipoprotein B Concentration
|
99.0 mg/dL
STANDARD_DEVIATION 20.0 • n=5 Participants
|
100.6 mg/dL
STANDARD_DEVIATION 20.0 • n=7 Participants
|
105.1 mg/dL
STANDARD_DEVIATION 31.2 • n=5 Participants
|
102.2 mg/dL
STANDARD_DEVIATION 24.7 • n=4 Participants
|
85.7 mg/dL
STANDARD_DEVIATION 18.4 • n=21 Participants
|
82.7 mg/dL
STANDARD_DEVIATION 14.6 • n=10 Participants
|
87.2 mg/dL
STANDARD_DEVIATION 19.1 • n=115 Participants
|
87.7 mg/dL
STANDARD_DEVIATION 19.6 • n=6 Participants
|
93.7 mg/dL
STANDARD_DEVIATION 22.8 • n=6 Participants
|
|
Total Cholesterol Concentration
|
199.5 mg/dL
STANDARD_DEVIATION 30.7 • n=5 Participants
|
199.4 mg/dL
STANDARD_DEVIATION 33.2 • n=7 Participants
|
210.4 mg/dL
STANDARD_DEVIATION 47.9 • n=5 Participants
|
202.5 mg/dL
STANDARD_DEVIATION 38.4 • n=4 Participants
|
177.8 mg/dL
STANDARD_DEVIATION 33.0 • n=21 Participants
|
173.6 mg/dL
STANDARD_DEVIATION 29.2 • n=10 Participants
|
177.7 mg/dL
STANDARD_DEVIATION 26.2 • n=115 Participants
|
179.0 mg/dL
STANDARD_DEVIATION 29.4 • n=6 Participants
|
189.8 mg/dL
STANDARD_DEVIATION 36.3 • n=6 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
3.618 ratio
STANDARD_DEVIATION 0.891 • n=5 Participants
|
3.579 ratio
STANDARD_DEVIATION 0.827 • n=7 Participants
|
3.743 ratio
STANDARD_DEVIATION 1.186 • n=5 Participants
|
3.933 ratio
STANDARD_DEVIATION 1.295 • n=4 Participants
|
3.116 ratio
STANDARD_DEVIATION 0.760 • n=21 Participants
|
3.170 ratio
STANDARD_DEVIATION 0.612 • n=10 Participants
|
3.392 ratio
STANDARD_DEVIATION 1.112 • n=115 Participants
|
3.400 ratio
STANDARD_DEVIATION 1.071 • n=6 Participants
|
3.491 ratio
STANDARD_DEVIATION 1.018 • n=6 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.633 ratio
STANDARD_DEVIATION 0.160 • n=5 Participants
|
0.628 ratio
STANDARD_DEVIATION 0.152 • n=7 Participants
|
0.643 ratio
STANDARD_DEVIATION 0.223 • n=5 Participants
|
0.658 ratio
STANDARD_DEVIATION 0.235 • n=4 Participants
|
0.529 ratio
STANDARD_DEVIATION 0.118 • n=21 Participants
|
0.524 ratio
STANDARD_DEVIATION 0.108 • n=10 Participants
|
0.575 ratio
STANDARD_DEVIATION 0.177 • n=115 Participants
|
0.576 ratio
STANDARD_DEVIATION 0.176 • n=6 Participants
|
0.595 ratio
STANDARD_DEVIATION 0.179 • n=6 Participants
|
|
Lipoprotein(a) Concentration
|
35.0 nmol/L
n=5 Participants
|
29.5 nmol/L
n=7 Participants
|
36.0 nmol/L
n=5 Participants
|
36.5 nmol/L
n=4 Participants
|
30.0 nmol/L
n=21 Participants
|
35.0 nmol/L
n=10 Participants
|
33.0 nmol/L
n=115 Participants
|
28.0 nmol/L
n=6 Participants
|
33.0 nmol/L
n=6 Participants
|
|
Triglyceride Concentration
|
125.0 mg/dL
n=5 Participants
|
128.5 mg/dL
n=7 Participants
|
125.0 mg/dL
n=5 Participants
|
132.0 mg/dL
n=4 Participants
|
120.0 mg/dL
n=21 Participants
|
120.0 mg/dL
n=10 Participants
|
109.0 mg/dL
n=115 Participants
|
113.0 mg/dL
n=6 Participants
|
121.5 mg/dL
n=6 Participants
|
|
HDL-C Concentration
|
57.5 mg/dL
STANDARD_DEVIATION 13.6 • n=5 Participants
|
58.3 mg/dL
STANDARD_DEVIATION 14.6 • n=7 Participants
|
58.6 mg/dL
STANDARD_DEVIATION 12.7 • n=5 Participants
|
54.7 mg/dL
STANDARD_DEVIATION 13.9 • n=4 Participants
|
59.6 mg/dL
STANDARD_DEVIATION 15.4 • n=21 Participants
|
56.0 mg/dL
STANDARD_DEVIATION 11.3 • n=10 Participants
|
55.9 mg/dL
STANDARD_DEVIATION 14.4 • n=115 Participants
|
56.3 mg/dL
STANDARD_DEVIATION 15.7 • n=6 Participants
|
57.1 mg/dL
STANDARD_DEVIATION 14.0 • n=6 Participants
|
|
Very-Low-Density Lipoprotein Cholesterol (VLDL-C) Concentration
|
26.3 mg/dL
STANDARD_DEVIATION 11.0 • n=5 Participants
|
26.8 mg/dL
STANDARD_DEVIATION 10.2 • n=7 Participants
|
29.2 mg/dL
STANDARD_DEVIATION 14.7 • n=5 Participants
|
29.0 mg/dL
STANDARD_DEVIATION 12.8 • n=4 Participants
|
27.4 mg/dL
STANDARD_DEVIATION 12.0 • n=21 Participants
|
25.1 mg/dL
STANDARD_DEVIATION 9.4 • n=10 Participants
|
24.3 mg/dL
STANDARD_DEVIATION 10.7 • n=115 Participants
|
24.7 mg/dL
STANDARD_DEVIATION 10.3 • n=6 Participants
|
26.6 mg/dL
STANDARD_DEVIATION 11.5 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
|
0.27 percent change
Standard Error 2.21
|
3.91 percent change
Standard Error 2.09
|
-73.70 percent change
Standard Error 2.26
|
-69.98 percent change
Standard Error 2.02
|
-0.42 percent change
Standard Error 3.26
|
-2.67 percent change
Standard Error 2.31
|
-74.82 percent change
Standard Error 3.26
|
-76.93 percent change
Standard Error 2.24
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
1.28 percent change
Standard Error 2.43
|
5.29 percent change
Standard Error 2.19
|
-73.57 percent change
Standard Error 2.48
|
-64.62 percent change
Standard Error 2.12
|
1.39 percent change
Standard Error 3.51
|
-3.49 percent change
Standard Error 2.67
|
-74.46 percent change
Standard Error 3.50
|
-70.36 percent change
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-14.8 mg/dL
Standard Error 4.3
|
-2.6 mg/dL
Standard Error 4.3
|
-104.1 mg/dL
Standard Error 4.4
|
-88.9 mg/dL
Standard Error 4.1
|
-8.9 mg/dL
Standard Error 3.2
|
-5.7 mg/dL
Standard Error 3.7
|
-77.6 mg/dL
Standard Error 3.2
|
-77.7 mg/dL
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
-13.7 mg/dL
Standard Error 4.6
|
-0.4 mg/dL
Standard Error 4.3
|
-104.5 mg/dL
Standard Error 4.6
|
-84.0 mg/dL
Standard Error 4.2
|
-7.7 mg/dL
Standard Error 3.3
|
-6.2 mg/dL
Standard Error 4.0
|
-77.2 mg/dL
Standard Error 3.3
|
-71.7 mg/dL
Standard Error 3.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
|
0.18 percent change
Standard Error 2.13
|
4.26 percent change
Standard Error 1.86
|
-68.48 percent change
Standard Error 2.18
|
-61.69 percent change
Standard Error 1.80
|
-1.57 percent change
Standard Error 2.45
|
-1.79 percent change
Standard Error 1.94
|
-69.72 percent change
Standard Error 2.45
|
-69.07 percent change
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
1.12 percent change
Standard Error 2.30
|
5.55 percent change
Standard Error 2.02
|
-67.81 percent change
Standard Error 2.35
|
-58.03 percent change
Standard Error 1.96
|
-0.07 percent change
Standard Error 2.68
|
-2.38 percent change
Standard Error 2.22
|
-68.89 percent change
Standard Error 2.67
|
-63.27 percent change
Standard Error 2.16
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
|
-0.32 percent change
Standard Error 1.98
|
0.76 percent change
Standard Error 2.06
|
-64.76 percent change
Standard Error 2.03
|
-58.47 percent change
Standard Error 1.99
|
-4.32 percent change
Standard Error 2.27
|
-0.85 percent change
Standard Error 1.90
|
-64.38 percent change
Standard Error 2.27
|
-64.24 percent change
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
0.74 percent change
Standard Error 2.17
|
2.42 percent change
Standard Error 2.26
|
-64.83 percent change
Standard Error 2.22
|
-54.80 percent change
Standard Error 2.19
|
-2.47 percent change
Standard Error 2.48
|
-1.89 percent change
Standard Error 2.17
|
-62.83 percent change
Standard Error 2.47
|
-58.04 percent change
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
|
-2.49 percent change
Standard Error 1.81
|
1.09 percent change
Standard Error 1.63
|
-48.03 percent change
Standard Error 1.85
|
-42.34 percent change
Standard Error 1.58
|
-4.21 percent change
Standard Error 1.86
|
-2.35 percent change
Standard Error 1.68
|
-45.19 percent change
Standard Error 1.86
|
-45.49 percent change
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 12
|
-1.70 percent change
Standard Error 1.97
|
2.29 percent change
Standard Error 1.67
|
-47.14 percent change
Standard Error 2.01
|
-39.06 percent change
Standard Error 1.62
|
-3.08 percent change
Standard Error 2.00
|
-2.44 percent change
Standard Error 1.81
|
-44.04 percent change
Standard Error 1.99
|
-40.88 percent change
Standard Error 1.76
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
|
3.77 percent change
Standard Error 2.11
|
3.94 percent change
Standard Error 2.16
|
-51.00 percent change
Standard Error 2.16
|
-48.71 percent change
Standard Error 2.09
|
1.04 percent change
Standard Error 1.82
|
1.58 percent change
Standard Error 2.04
|
-49.79 percent change
Standard Error 1.81
|
-48.11 percent change
Standard Error 1.98
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
|
4.73 percent change
Standard Error 2.36
|
4.33 percent change
Standard Error 2.33
|
-50.72 percent change
Standard Error 2.40
|
-46.62 percent change
Standard Error 2.26
|
1.84 percent change
Standard Error 2.01
|
0.83 percent change
Standard Error 2.20
|
-49.52 percent change
Standard Error 2.00
|
-44.61 percent change
Standard Error 2.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12
|
0.06 percent change
Standard Error 2.02
|
2.79 percent change
Standard Error 2.37
|
-66.41 percent change
Standard Error 2.07
|
-61.55 percent change
Standard Error 2.29
|
-1.92 percent change
Standard Error 2.30
|
1.54 percent change
Standard Error 2.09
|
-65.97 percent change
Standard Error 2.30
|
-65.72 percent change
Standard Error 2.02
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
|
0.71 percent change
Standard Error 2.11
|
4.08 percent change
Standard Error 2.62
|
-67.59 percent change
Standard Error 2.16
|
-58.45 percent change
Standard Error 2.53
|
-1.15 percent change
Standard Error 2.47
|
0.06 percent change
Standard Error 2.30
|
-65.11 percent change
Standard Error 2.46
|
-60.56 percent change
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
|
0.0 percentage of participants
95% Confidence Interval 2.02 • Interval 0.0 to 7.3
|
0.0 percentage of participants
95% Confidence Interval 2.37 • Interval 0.0 to 7.3
|
98.0 percentage of participants
95% Confidence Interval 2.07 • Interval 89.5 to 99.6
|
96.0 percentage of participants
95% Confidence Interval 2.29 • Interval 86.5 to 98.9
|
22.4 percentage of participants
95% Confidence Interval 2.30 • Interval 13.0 to 35.9
|
15.7 percentage of participants
95% Confidence Interval 2.09 • Interval 8.2 to 28.0
|
96.0 percentage of participants
95% Confidence Interval 2.30 • Interval 86.5 to 98.9
|
98.0 percentage of participants
95% Confidence Interval 2.02 • Interval 89.7 to 99.7
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
|
0.0 percentage of participants
95% Confidence Interval 2.02 • Interval 0.0 to 7.3
|
4.2 percentage of participants
95% Confidence Interval 2.37 • Interval 1.2 to 14.0
|
98.0 percentage of participants
95% Confidence Interval 2.07 • Interval 89.3 to 99.6
|
96.0 percentage of participants
95% Confidence Interval 2.29 • Interval 86.5 to 98.9
|
20.4 percentage of participants
95% Confidence Interval 2.30 • Interval 11.5 to 33.6
|
20.0 percentage of participants
95% Confidence Interval 2.09 • Interval 11.2 to 33.0
|
96.0 percentage of participants
95% Confidence Interval 2.30 • Interval 86.5 to 98.9
|
98.0 percentage of participants
95% Confidence Interval 2.02 • Interval 89.7 to 99.7
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
|
5.23 percent change
Standard Error 6.18
|
4.07 percent change
Standard Error 4.95
|
-45.97 percent change
Standard Error 6.27
|
-45.01 percent change
Standard Error 4.78
|
6.52 percent change
Standard Error 4.81
|
-5.62 percent change
Standard Error 5.00
|
-43.03 percent change
Standard Error 4.81
|
-49.55 percent change
Standard Error 4.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 12
|
4.35 percent change
Standard Error 6.86
|
7.03 percent change
Standard Error 5.47
|
-45.72 percent change
Standard Error 6.93
|
-41.74 percent change
Standard Error 5.29
|
10.75 percent change
Standard Error 5.15
|
-5.73 percent change
Standard Error 5.18
|
-41.93 percent change
Standard Error 5.13
|
-45.70 percent change
Standard Error 5.02
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
|
4.69 percent change
Standard Error 6.04
|
4.54 percent change
Standard Error 5.31
|
-23.23 percent change
Standard Error 6.15
|
-17.41 percent change
Standard Error 5.14
|
-2.11 percent change
Standard Error 4.45
|
8.06 percent change
Standard Error 6.16
|
-22.12 percent change
Standard Error 4.44
|
-12.66 percent change
Standard Error 6.01
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
7.84 percent change
Standard Error 7.65
|
4.34 percent change
Standard Error 5.61
|
-19.73 percent change
Standard Error 7.74
|
-15.63 percent change
Standard Error 5.43
|
-3.88 percent change
Standard Error 4.85
|
7.30 percent change
Standard Error 6.42
|
-21.05 percent change
Standard Error 4.82
|
-9.63 percent change
Standard Error 6.26
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
|
-4.83 percent change
Standard Error 2.25
|
-1.57 percent change
Standard Error 2.29
|
7.50 percent change
Standard Error 2.30
|
13.05 percent change
Standard Error 2.22
|
-4.03 percent change
Standard Error 2.34
|
-3.06 percent change
Standard Error 2.13
|
11.34 percent change
Standard Error 2.33
|
6.09 percent change
Standard Error 2.07
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12
|
-4.59 percent change
Standard Error 2.58
|
-0.40 percent change
Standard Error 2.47
|
8.88 percent change
Standard Error 2.62
|
14.80 percent change
Standard Error 2.39
|
-3.57 percent change
Standard Error 2.59
|
-2.36 percent change
Standard Error 2.38
|
13.28 percent change
Standard Error 2.58
|
7.84 percent change
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
|
2.57 percent change
Standard Error 5.52
|
3.10 percent change
Standard Error 5.12
|
-25.29 percent change
Standard Error 5.65
|
-19.55 percent change
Standard Error 4.95
|
-1.32 percent change
Standard Error 4.32
|
9.96 percent change
Standard Error 5.57
|
-19.41 percent change
Standard Error 4.31
|
-17.20 percent change
Standard Error 5.46
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A5 Placebo Q2W
n=49 Participants
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 Participants
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 Participants
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 Participants
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in VLDL-C at Week 12
|
4.09 percent change
Standard Error 6.22
|
2.92 percent change
Standard Error 5.45
|
-24.33 percent change
Standard Error 6.34
|
-17.89 percent change
Standard Error 5.27
|
-3.03 percent change
Standard Error 4.70
|
9.17 percent change
Standard Error 5.63
|
-18.08 percent change
Standard Error 4.68
|
-15.18 percent change
Standard Error 5.52
|
Adverse Events
A5 Placebo Q2W
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
A5 Placebo QM
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
A5 Evolocumab Q2W
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
A5 Evolocumab QM
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
A20 Placebo Q2W
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
A20 Placebo QM
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
A20 Evolocumab Q2W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
A20 Evolocumab QM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A5 Placebo Q2W
n=49 participants at risk
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 participants at risk
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
2.0%
1/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
A5 Placebo Q2W
n=49 participants at risk
Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
A5 Placebo QM
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
|
A5 Evolocumab Q2W
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A5 Evolocumab QM
n=50 participants at risk
Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
A20 Placebo Q2W
n=52 participants at risk
Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Placebo QM
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
|
A20 Evolocumab Q2W
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
A20 Evolocumab QM
n=51 participants at risk
Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
2/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
10/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
10/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.0%
12/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.0%
7/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.6%
5/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.6%
11/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.7%
7/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.7%
8/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/49 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
2/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER