NIPH Clinical Trials Search

STRENGTH

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Hypertriglyceridemia at high risk for a future cardiovascular event
Date of first enrollment	19/05/2015
Target sample size	305
Countries of recruitment	Japan,Asia except Japan,North America,South America,Europe,Oceania,Africa
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Epanova INN of investigational material : omega-3 carboxylic acids Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : 4g/day control material(s) Generic name etc : Corn oil INN of investigational material : corn oil Therapeutic category code : --- Other Dosage and Administration for Investigational material : 4g/day

Outcome(s)

Primary Outcome	efficacy -
Secondary Outcome	safety efficacy -

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Patient must be on a stable diet and statin therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: a. LDL-C <100 mg/dL b. TG level 180 or more 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: a. Any atherosclerotic CVD as defined in protocol. b. History of diabetes mellitus (type 1 or 2) and 40 years of age or more for men and 50 years of age or omore for women, plus one of the risk factors defined in protocol. c. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
Exclude criteria	- Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. - Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. - Statin naive at Visit 1.