A study to determine the effectiveness and safety of AMR101 in reducing the risk of cardiovascular events (e.g. stroke, heart attack, unstable angina) in patients with high triglyceride levels and who are on statin treatments.
- Conditions
- Health Condition 1: null- Cardiovascular Diseases
- Registration Number
- CTRI/2012/05/002653
- Lead Sponsor
- Amarin Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 7990
•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
•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:
oniacin 200 mg/day or fibrates;
oany omega-3 fatty acid medications;
odietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
obile acid sequestrants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method