Clareo Health | A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amarin Pharma Inc.
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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);
