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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. (REDUCE-IT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Amarin Pharma Inc. Identifier:
First received: December 13, 2011
Last updated: March 15, 2017
Last verified: March 2017
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 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.

Condition Intervention Phase
Cardiovascular Diseases
Drug: AMR101
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Amarin Pharma Inc.:

Primary Outcome Measures:
  • Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina. [ Time Frame: 4-6 years ]

Secondary Outcome Measures:
  • Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ]

Estimated Enrollment: 8000
Study Start Date: November 2011
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMR101 Drug: AMR101
Parallel Assignment
Other Name: VASCEPA® (icosapent ethyl)
Placebo Comparator: Placebo Drug: Placebo
Parallel Assignment


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01492361

  Show 410 Study Locations
Sponsors and Collaborators
Amarin Pharma Inc.
Principal Investigator: Deepak L. Bhatt, MD, MPH Brigham and Women's Hospital, 75 Francis Street, Boston
  More Information

Responsible Party: Amarin Pharma Inc. Identifier: NCT01492361     History of Changes
Other Study ID Numbers: AMR-01-01-0019
Study First Received: December 13, 2011
Last Updated: March 15, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Amarin Pharma Inc.:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
omega-3 fatty acids
docosahexaenoic acid
fatty acids

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors processed this record on April 28, 2017