Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

• Status: Completed
• Trial end date: 2013-10-29
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or female ≥ 18 to ≤ 80 years of age

• National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less

• Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL

• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

• History of coronary heart disease

• New York Heart Association (NYHA) III or IV heart failure

• Uncontrolled cardiac arrhythmia

• Uncontrolled hypertension

• Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)

• Uncontrolled hypothyroidism or hyperthyroidism