Trial Outcomes & Findings for A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects (NCT NCT01652703)
NCT ID: NCT01652703
Last Updated: 2018-11-28
Results Overview
LDL-C was measured using ultracentrifugation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
310 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-11-28
Participant Flow
Japanese men or women ≥ 20 to ≤ 80 years of age and who were at high risk for cardiovascular events, on a stable dose of an approved statin (with or without ezetimibe) and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 115 mg/dL. First patient enrolled on 10 July 2012; last patient enrolled 19 February 2013.
Randomization was stratified by screening LDL-C level (\< 130 mg/dL \[3.4 mmol/L\] vs ≥ 130 mg/dL) and by diagnosis of heterozygous familial hypercholesterolemia (HeFH) (yes vs no).
Participant milestones
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
50
|
52
|
52
|
53
|
|
Overall Study
Received Treatment
|
52
|
50
|
49
|
52
|
51
|
53
|
|
Overall Study
COMPLETED
|
52
|
50
|
47
|
50
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
1
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
61.6 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
61.3 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
193 Participants
n=8 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=8 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
49 participants
n=5 Participants
|
52 participants
n=4 Participants
|
51 participants
n=21 Participants
|
53 participants
n=8 Participants
|
307 participants
n=8 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=8 Participants
|
0 participants
n=8 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=8 Participants
|
0 participants
n=8 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=8 Participants
|
0 participants
n=8 Participants
|
|
Stratification Factor: LDL Level
< 130 mg/dL
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
17 participants
n=4 Participants
|
15 participants
n=21 Participants
|
17 participants
n=8 Participants
|
98 participants
n=8 Participants
|
|
Stratification Factor: LDL Level
≥ 130 mg/dL
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
34 participants
n=5 Participants
|
35 participants
n=4 Participants
|
36 participants
n=21 Participants
|
36 participants
n=8 Participants
|
209 participants
n=8 Participants
|
|
Stratification Factor: Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
No
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
47 participants
n=5 Participants
|
49 participants
n=4 Participants
|
47 participants
n=21 Participants
|
49 participants
n=8 Participants
|
287 participants
n=8 Participants
|
|
Stratification Factor: Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
Yes
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
20 participants
n=8 Participants
|
|
LDL-C Concentration
|
144.4 mg/dL
STANDARD_DEVIATION 18.1 • n=5 Participants
|
141.8 mg/dL
STANDARD_DEVIATION 23.4 • n=7 Participants
|
143.6 mg/dL
STANDARD_DEVIATION 20.6 • n=5 Participants
|
140.7 mg/dL
STANDARD_DEVIATION 23.3 • n=4 Participants
|
141.0 mg/dL
STANDARD_DEVIATION 21.2 • n=21 Participants
|
139.7 mg/dL
STANDARD_DEVIATION 18.8 • n=8 Participants
|
141.8 mg/dL
STANDARD_DEVIATION 20.9 • n=8 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
171.3 mg/dL
STANDARD_DEVIATION 23.0 • n=5 Participants
|
168.7 mg/dL
STANDARD_DEVIATION 26.1 • n=7 Participants
|
170.6 mg/dL
STANDARD_DEVIATION 27.2 • n=5 Participants
|
166.3 mg/dL
STANDARD_DEVIATION 26.2 • n=4 Participants
|
165.5 mg/dL
STANDARD_DEVIATION 24.4 • n=21 Participants
|
166.7 mg/dL
STANDARD_DEVIATION 23.5 • n=8 Participants
|
168.2 mg/dL
STANDARD_DEVIATION 25.0 • n=8 Participants
|
|
Apolipoprotein B Concentration
|
114.6 mg/dL
STANDARD_DEVIATION 15.4 • n=5 Participants
|
112.5 mg/dL
STANDARD_DEVIATION 16.6 • n=7 Participants
|
113.1 mg/dL
STANDARD_DEVIATION 19.2 • n=5 Participants
|
109.4 mg/dL
STANDARD_DEVIATION 16.0 • n=4 Participants
|
109.6 mg/dL
STANDARD_DEVIATION 16.9 • n=21 Participants
|
109.8 mg/dL
STANDARD_DEVIATION 15.9 • n=8 Participants
|
111.5 mg/dL
STANDARD_DEVIATION 16.7 • n=8 Participants
|
|
Very Low-Density Lipoprotein Cholesterol (VLDL-C) Concentration
|
26.9 mg/dL
STANDARD_DEVIATION 10.5 • n=5 Participants
|
27.1 mg/dL
STANDARD_DEVIATION 10.7 • n=7 Participants
|
26.9 mg/dL
STANDARD_DEVIATION 13.3 • n=5 Participants
|
25.6 mg/dL
STANDARD_DEVIATION 10.8 • n=4 Participants
|
24.6 mg/dL
STANDARD_DEVIATION 10.5 • n=21 Participants
|
27.0 mg/dL
STANDARD_DEVIATION 12.0 • n=8 Participants
|
26.4 mg/dL
STANDARD_DEVIATION 11.3 • n=8 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
4.380 ratio
STANDARD_DEVIATION 0.949 • n=5 Participants
|
4.317 ratio
STANDARD_DEVIATION 1.075 • n=7 Participants
|
4.366 ratio
STANDARD_DEVIATION 1.177 • n=5 Participants
|
4.302 ratio
STANDARD_DEVIATION 1.039 • n=4 Participants
|
4.228 ratio
STANDARD_DEVIATION 0.993 • n=21 Participants
|
4.210 ratio
STANDARD_DEVIATION 0.955 • n=8 Participants
|
4.300 ratio
STANDARD_DEVIATION 1.026 • n=8 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.750 ratio
STANDARD_DEVIATION 0.150 • n=5 Participants
|
0.741 ratio
STANDARD_DEVIATION 0.177 • n=7 Participants
|
0.743 ratio
STANDARD_DEVIATION 0.177 • n=5 Participants
|
0.722 ratio
STANDARD_DEVIATION 0.163 • n=4 Participants
|
0.725 ratio
STANDARD_DEVIATION 0.151 • n=21 Participants
|
0.714 ratio
STANDARD_DEVIATION 0.158 • n=8 Participants
|
0.732 ratio
STANDARD_DEVIATION 0.162 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.
LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-2.71 percent change
Standard Error 2.16
|
0.05 percent change
Standard Error 2.32
|
-55.56 percent change
Standard Error 2.23
|
-71.32 percent change
Standard Error 2.16
|
-58.10 percent change
Standard Error 2.33
|
-63.89 percent change
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-1.8 mg/dL
Standard Error 3.6
|
0.8 mg/dL
Standard Error 3.4
|
-77.2 mg/dL
Standard Error 3.7
|
-98.0 mg/dL
Standard Error 3.6
|
-79.9 mg/dL
Standard Error 3.4
|
-87.4 mg/dL
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
An LDL-C response was defined as LDL-C \< 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an LDL-C Response at Week 12
|
0.0 percentage of participants
3.6
|
0.0 percentage of participants
3.4
|
66.0 percentage of participants
3.7
|
96.0 percentage of participants
3.6
|
80.4 percentage of participants
3.4
|
82.4 percentage of participants
3.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 12 in Non-HDL-C
|
-2.20 percent change
Standard Error 1.94
|
0.55 percent change
Standard Error 2.17
|
-51.66 percent change
Standard Error 2.00
|
-64.76 percent change
Standard Error 1.94
|
-53.00 percent change
Standard Error 2.17
|
-57.53 percent change
Standard Error 2.12
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 12 in Apolipoprotein B
|
-0.90 percent change
Standard Error 1.82
|
0.22 percent change
Standard Error 2.02
|
-47.65 percent change
Standard Error 1.88
|
-61.59 percent change
Standard Error 1.82
|
-47.16 percent change
Standard Error 2.03
|
-53.22 percent change
Standard Error 1.98
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 12 in VLDL-C
|
8.23 percent change
Standard Error 8.55
|
7.26 percent change
Standard Error 6.87
|
-16.02 percent change
Standard Error 8.74
|
-26.26 percent change
Standard Error 8.44
|
-13.56 percent change
Standard Error 6.80
|
-22.56 percent change
Standard Error 6.71
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio
|
-4.82 percent change
Standard Error 1.91
|
1.19 percent change
Standard Error 2.09
|
-42.04 percent change
Standard Error 1.98
|
-51.81 percent change
Standard Error 1.91
|
-44.11 percent change
Standard Error 2.10
|
-45.47 percent change
Standard Error 2.05
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=52 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=49 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=52 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=51 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=53 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio
|
-3.18 percent change
Standard Error 2.12
|
1.44 percent change
Standard Error 2.21
|
-50.71 percent change
Standard Error 2.19
|
-64.53 percent change
Standard Error 2.12
|
-50.79 percent change
Standard Error 2.22
|
-56.31 percent change
Standard Error 2.16
|
Adverse Events
Placebo Q2W
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Q4W
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Evolocumab Q2W 70 MG
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Evolocumab Q2W 140 MG
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Evolocumab Q4W 280 MG
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Evolocumab Q4W 420 MG
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=52 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab Q2W 70 MG
n=49 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab Q2W 140 MG
n=52 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab Q4W 280 MG
n=51 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab Q4W 420 MG
n=53 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/49 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/53 • 12 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)
Carcinoid tumour of the caecum
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/49 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/53 • 12 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)
Prostate cancer
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/49 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/53 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/50 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/49 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/53 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo Q2W
n=52 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=50 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab Q2W 70 MG
n=49 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab Q2W 140 MG
n=52 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab Q4W 280 MG
n=51 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab Q4W 420 MG
n=53 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.5%
6/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
6/50 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.4%
10/49 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.3%
9/52 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
23.5%
12/51 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.1%
8/53 • 12 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