A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

20110115

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

2013-01-15

2013-11-12

2013-12-04

Completed

Early phase I

2067

Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L) * Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L) * Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L) * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * Statin intolerance * New York Heart association (NYHA) III or IV heart failure * Uncontrolled hypertension * Uncontrolled cardiac arrhythmia * Type 1 diabetes, poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2067, 'type': 'ACTUAL'}}

2022-11-08