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 currently recruiting participants.

Verified March 2012 by Amarin Pharma Inc.

Sponsor:

Information provided by (Responsible Party):

Amarin Pharma Inc.

ClinicalTrials.gov Identifier:

NCT01492361

First received: December 13, 2011

Last updated: March 16, 2012

Last verified: March 2012

History of Changes

Purpose

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: Double Blind (Subject, 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:

MedlinePlus related topics: Angina Coronary Artery Disease Statins Triglycerides

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	8000
Study Start Date:	November 2011
Estimated Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AMR101	Drug: AMR101 Parallel Assignment
Placebo Comparator: Placebo	Drug: Placebo Parallel Assignment

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 fish oil products
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492361

Contacts

Contact: Stacey Bilinski

609-951-6833

sbilinski@pharmanet.com

Show 51 Study Locations

Sponsors and Collaborators

Amarin Pharma Inc.

More Information

No publications provided

Responsible Party:	Amarin Pharma Inc.
ClinicalTrials.gov Identifier:	NCT01492361 History of Changes
Other Study ID Numbers:	AMR-01-01-0019
Study First Received:	December 13, 2011
Last Updated:	March 16, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada India: Drugs Controller General of India Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Ukraine: Ministry of Health United States: Food and Drug Administration

Keywords provided by Amarin Pharma Inc.:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
hypertriglyceridemia

omega-3 fatty acids
statin
triglycerides
EPA
docosahexaenoic acid
fish
fatty acids
fibrates
niacin
lipids
lipoprotein
atorvastatin
Lovaza
simvastatin
lovastatin

Additional relevant MeSH terms:

Cardiovascular Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents

Hypolipidemic Agents
Lipid Regulating Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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