A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event.



Status:Completed
Conditions:Peripheral Vascular Disease, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:45 - Any
Updated:10/18/2018
Start Date:November 2011
End Date:May 2018

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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)

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic
acid (EPA) being developed by Amarin Pharma Inc. for the treatment of cardiovascular disease
in statin-treated patients with hypertriglyceridemia. The purpose of this study is to
evaluate whether this drug, combined with a statin therapy, will be superior to the statin
therapy alone, when used as a prevention in reducing long-term cardiovascular events in
high-risk patients with mixed dyslipidemia.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 the study product, fish and/or shellfish, or placebo

- History of acute or chronic pancreatitis

- Patients are excluded if using the following medications:

- PCSK9 inhibitors

- niacin >200 mg/day or fibrates;

- any omega-3 fatty acid medications ;

- dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil,
krill oil, or algal oil);

- bile acid sequestrants
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