NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Hypertriglyceridemia
Date of first enrollment	17/06/2015
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AZD0585 INN of investigational material : omega-3 fatty acids Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : 2g once-daily or 4g once-daily control material(s) Generic name etc : AZD0585 placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : 4g once-daily

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Subjects must meet all of the following criteria; a. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL b. %TG change between Visit 2 and Visit 3 must be within 30% c. %LDL-C change between Visit 2 and Visit 3 must be within 25%
Exclude criteria	- Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters. - Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-2 deficiency or familial dysbetalipoproteinemia. - Current or history of pancreatitis. - Type 1 diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.