Status:
COMPLETED
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Lead Sponsor:
Amarin Pharma Inc.
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
8179 Patients enrolled
Trial Details
Trial ID
NCT01492361
Start Date
November 1 2011
End Date
May 1 2018
Last Update
April 14 2022
Active Locations (410)
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1
Amarin Investigational Site
Birmingham, Alabama, United States, 35205
2
Amarin Investigational Site
Birmingham, Alabama, United States, 35235
3
Amarin Investigational Site
Huntsville, Alabama, United States, 35801
4
Amarin Investigational Site
Mobile, Alabama, United States, 36608