Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

• Status: Completed
• Trial end date: 2012-05-08
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

• 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

• On a statin or a low dose statin with stable dose for at least 4 weeks

• Lipid lowering therapy has been stable prior to enrollment

• Fasting triglycerides must be < 400 mg/dL.

• Subject not at LDL-C goal

Exclusion Criteria:

• New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%

• Uncontrolled cardiac arrhythmia

• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

• Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)

• Uncontrolled hypertension