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Amarin Taps CRO for Phase 3 Cardiovascular Trials

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By: Sean Moloughney

Editor, Nutraceuticals World

London-based Amarin Corporation has executed an agreement with Medpace, Inc., a contract research organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 (an ultra-pure ethyl ester of EPA) in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia. The study will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels of ≥500 mg/dL. The Phase 3 mixed dyslipidemia trial will evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels of ≥200 mg/dL and <500 mg/dL who are on statin therapy.

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