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Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

REDUCE-IT [NCT01492361]

Description: Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

Drug: AMR101; Drug: Placebo

  • Phase III

Primary Investigator: Kereiakes

Enrolling
Drug/Device Information
AMR101 vs placebo in reducing clinical events in patients with mixed dyslipidemia at high risk for cardiovascular events
AMR101 is a highly purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil
5 year event trial
Amarin
Major Inclusion and Exclusion
Must be on stable statin therapy (with or without ezetimibe)
Fasting triglyceride ≥ 135 mg/dL and <500 mg/dL
Established cardiovascular disease or at high risk for cardiovascular disease
No fibrates or niacin >200 mg/day
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