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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.

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.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222886
Enrollment
Unknown
Registered
2015-06-17
Start date
2015-06-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Interventions

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 In

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026