Amarin Announces Enrollment of the REDUCE-IT Cardiovascular Outcomes Study Surpasses 6,000 Patients

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   Evaluating the Effectiveness of Vascepa(R) in Reducing
   Major Events in a High-Risk Patient Population

BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 25, 2013 (GLOBE NEWSWIRE)
Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the number of enrolled in the company’s REDUCE-IT cardiovascular study of Vascepa(R) (icosapent ethyl) capsules has surpassed 6,000.

The REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial) study is a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study taking place at over 400 clinical sites in 11 countries to evaluate the effectiveness and safety of Vascepa(R) (icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major cardiovascular events in a patient population at high risk for such events. The control arm of the study consists of patients on optimized statin therapy plus placebo. The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies. Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL. In addition, all patients enrolled in the study have either documented cardiovascular disease (CVD) or are at high-risk for CVD.

The REDUCE-IT study is being conducted under Amarin’s previously announced Special Protocol Assessment (SPA) agreement with the U.S.
Food and Drug Administration (FDA). An SPA agreement is an agreement with the FDA that the Phase 3 trial protocol design,…Read more

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