JPRN-jRCT2080222886
Unknown
Phase 3
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.
ConditionsHypertriglyceridemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertriglyceridemia
- Sponsor
- AstraZeneca
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
Outcomes
Primary Outcomes
Not specified
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