A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate 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 â?? Intervention Trial) - REDUCE-IT

Amarin Pharma Inc0 个研究点目标入组 7,990 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Men and non-pregnant or sterile women ages 45 and older
•Hypertriglyceridemia
•On statin therapy for at least four weeks
•Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease

•Severe heart failure
•Any life-threatening disease other than Cardiovascular Disease
•Active severe liver disease
•Hemoglobin A1c 10.0%
•Poorly controlled hypertension
•Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
•Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
•Known hypersensitivity to fish oil products
•History of acute or chronic pancreatitis
•Patients are excluded if using the following medications:
•oniacin 200 mg/day or fibrates;
•oany omega-3 fatty acid medications;
•odietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
•obile acid sequestrants

发起方

Amarin Pharma Inc