Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

• Status: Completed
• Trial end date: 2013-10-14
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

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

Details

• Lead Sponsor: Amgen
• Treatments: Atorvastatin; Atorvastatin Calcium; Evolocumab; Ezetimibe

Criteria

Inclusion Criteria:

• Subject has provided informed consent.

• Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:

• < 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent

• < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent

• OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD

• Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

• New York Heart Association (NYHA) II-IV heart failure, or last 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, newly diagnosed or poorly controlled type 2 diabetes

• Uncontrolled hypertension