A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

20090159

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.

2011-07-28

2012-05-08

2012-05-08

Completed

Early phase I

160

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}

2022-11-07