A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

20110114

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

2013-01-21

2013-10-10

2013-10-29

Completed

Early phase I

615

Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less * Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \<190 mg/dL * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * History of coronary heart disease * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Diabetes mellitus (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': 615, 'type': 'ACTUAL'}}

2022-11-08