Status Enrollment Complete
Condition Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Description
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Drug: Epanova® (omega-3 carboxylic acids)
Drug: corn oil control
Purpose
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Phase III
Key Inclusion Criteria
- Men or women, ≥18 years of age.
- Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- LDL-C <100 mg/dL or LDL – C > 100 mg/dL under certain circumstances
- TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
- Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:
- Any atherosclerotic CVD as defined in protocol.
- History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
- Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
Key Exclusion Criteria
1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil.
2. Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. Potential patients may not be interested if they are on one of these medications since the washout allowance is not mentioned
3. Statin naïve at Visit 1.
4. Patients on dialysis.
ClinicalTrials.gov Identifier
NCT02104817
Protocol Number
D5881C00004
