Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to
 placebo in lowering fasting triglyceride levels in patients with very high fasting
 triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
Inclusion Criteria:

 -  Men and women, ages >18

 -  Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL

 -  Provide written informed consent and authorization for protected health information
 disclosure

 Exclusion Criteria:

 -  Women who are pregnant or lactating, or planning to become pregnant

 -  Use of non-statin lipid-altering drugs which cannot be stopped including fibrates,
 niacin, fish oil and other products containing omega-3 fatty acids or other dietary
 supplements with potential lipid-altering effects

 -  History of pancreatitis

 -  History of bariatric surgery or currently on weight loss drugs

 -  Uncontrolled hypertension (BP > 160/100)

 -  HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or
 isotretinoin

 -  Consumption of more than 2 alcoholic beverages per day

 -  History of cancers (except if been disease free for >5 years OR history was basal or
 squamous cell skin cancer)

 -  Participation in another clinical trial involving an investigational agent in the last
 30 days

 -  Other parameters will be assessed at the study center to ensure eligibility for this
 study.