A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
(REDUCE-IT Trial)
Recruiting in Palo Alto (17 mi)
+314 other locations
DL
Overseen byDeepak L. Bhatt, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Amarin Pharma Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was 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.
Research Team
DL
Deepak L. Bhatt, MD, MPH
Principal Investigator
Brigham and Women's Hospital, 75 Francis Street, Boston
Eligibility Criteria
Inclusion Criteria
Men and non-pregnant or sterile women ages 45 and older
Hypertriglyceridemia
On statin therapy for at least four weeks
See 1 more
Treatment Details
Interventions
- AMR101 (Omega-3 Fatty Acid)
- Placebo (Placebo)
- Statin therapy (Hormone Therapy)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AMR101Experimental Treatment2 Interventions
AMR101 (icosapent ethyl) + statin therapy, daily
Group II: PlaceboPlacebo Group2 Interventions
Placebo + statin therapy, daily
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Amarin Investigational SiteAlbuquerque, NM
Amarin Investigational SiteOcean City, NJ
Amarin Investigational SiteBend, OR
Amarin Investigational SiteHuntsville, AL
More Trial Locations
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Who Is Running the Clinical Trial?
Amarin Pharma Inc.
Lead Sponsor
Trials
7
Patients Recruited
19,200+