Overview

Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Status:
Completed

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Treatments:

Antibodies, Monoclonal
Atorvastatin
Atorvastatin Calcium
Evolocumab

Criteria

Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable
dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100
mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for
cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV -
heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes,
poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism