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Trial record 1 of 12 for:    Reduce-It
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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492361
First Posted: December 15, 2011
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amarin Pharma Inc.
December 13, 2011
December 15, 2011
March 17, 2017
November 2011
December 2017   (Final data collection date for primary outcome measure)
Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina. [ Time Frame: 4-6 years ]
Incidence of cardiovascular events, such as coronary revascularization. [ Time Frame: 4-6 years ]
Complete list of historical versions of study NCT01492361 on ClinicalTrials.gov Archive Site
Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ]
Same as current
Not Provided
Not Provided
 
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.
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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Drug: AMR101
    Parallel Assignment
    Other Name: VASCEPA® (icosapent ethyl)
  • Drug: Placebo
    Parallel Assignment
  • Experimental: AMR101
    Intervention: Drug: AMR101
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8000
Not Provided
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   India,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   South Africa,   Ukraine,   United States
 
 
NCT01492361
AMR-01-01-0019
Yes
Not Provided
Plan to Share IPD: Undecided
Amarin Pharma Inc.
Amarin Pharma Inc.
Not Provided
Principal Investigator: Deepak L. Bhatt, MD, MPH Brigham and Women's Hospital, 75 Francis Street, Boston
Amarin Pharma Inc.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP