A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase 3 Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.
Phase 3
- Conditions
- Hypertriglyceridemia
- Registration Number
- JPRN-jRCT2080222886
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion 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%
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method