Phase 2
Completed N=310
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
Hypercholesterolemia and High Risk for Cardiovascular Events
Source: ClinicalTrials.gov NCT01652703 ↗
Enrolled (actual)
310
Serious AEs
1.3%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -2.71; 0.05; -55.56; -71.32 percent change — p=<0.001
Summary
The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-2.71; 0.05; -55.56; -71.32; -58.10; -63.89 | <0.001 sig |
| SECONDARY Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-1.8; 0.8; -77.2; -98.0; -79.9; -87.4 | <0.001 sig |
| SECONDARY Percentage of Participants With an LDL-C Response at Week 12 |
0.0; 0.0; 66.0; 96.0; 80.4; 82.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Non-HDL-C |
-2.20; 0.55; -51.66; -64.76; -53.00; -57.53 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B |
-0.90; 0.22; -47.65; -61.59; -47.16; -53.22 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in VLDL-C |
8.23; 7.26; -16.02; -26.26; -13.56; -22.56 | 0.004 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio |
-4.82; 1.19; -42.04; -51.81; -44.11; -45.47 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio |
-3.18; 1.44; -50.71; -64.53; -50.79; -56.31 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction < 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.
Data sourced from ClinicalTrials.gov (NCT01652703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.