A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects

Phase 2

Completed

• Conditions: Hypercholesterolemia and High Risk for Cardiovascular Events
• Interventions: Other: Placebo; Biological: Evolocumab

• Registration Number: NCT01652703
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-10
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-30
• Primary Completion: 2013-05-14
• Disposition First Submitted: 2014-05-12
• Disposition First Submitted QC: 2014-05-12
• Disposition First Posted: 2014-05-26
• Results First Submitted: 2015-09-03
• Results First Submitted QC: 2015-09-03
• Results First Posted: 2015-10-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Q2W	Placebo	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Evolocumab 280 mg Q4W	Evolocumab	Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 70 mg Q2W	Evolocumab	Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Placebo Q4W	Placebo	Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Evolocumab 140 mg Q2W	Evolocumab	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 420 mg Q4W	Evolocumab	Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12	LDL-C was measured using ultracentrifugation.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 12 in Non-HDL-C	Baseline and Week 12
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12	LDL-C was measured using ultracentrifugation.
Percent Change From Baseline to Week 12 in Apolipoprotein B	Baseline and Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio	Baseline and Week 12
Percentage of Participants With an LDL-C Response at Week 12	Week 12	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.
Percent Change From Baseline to Week 12 in VLDL-C	Baseline and Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio	Baseline and Week 12

Trial Locations

Locations (1)

Research Site; 🇯🇵 Toshima-ku, Tokyo, Japan