A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia and High Cardiovascular Risk

Amgen1 site in 1 country310 target enrollmentJuly 10, 2012

ConditionsHypercholesterolemia and High Risk for Cardiovascular Events

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hypercholesterolemia and High Risk for Cardiovascular Events
Sponsor: Amgen
Enrollment: 310
Locations: 1
Primary Endpoint: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 10, 2012

End Date

May 14, 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time Frame: Baseline and Week 12

LDL-C was measured using ultracentrifugation.

Secondary Outcomes

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)
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)
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)