Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

• Status: Completed
• Trial end date: 2012-03-02
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Evolocumab; Ezetimibe

Criteria

Inclusion Criteria:

• Male or female ≥ 18 to ≤ 75 years of age

• Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL

• Framingham risk score of 10% or less

• Fasting triglycerides < 400 mg/dL

Exclusion Criteria:

• History of coronary heart disease

• New York Heart Association (NYHA) II - IV heart failure

• Uncontrolled cardiac arrhythmia

• Uncontrolled hypertension