LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects

20101155

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

2011-07-01

2012-04-05

2012-04-05

Completed

Early phase I

631

Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks * Fasting LDL-C ≥ 85 mg/dL * Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: * 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 (Glycosyated Hemoglobin (HbA1c) \> 8.5%) * Uncontrolled hypertension * New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30% * Uncontrolled cardiac arrhythmia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 631, 'type': 'ACTUAL'}}

2022-11-15