AZD0585 Phase III Long-term Study in Japan

• Status: Completed
• Trial end date: 2017-03-11
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Key Inclusion Criteria:

• Japanese men or women, ≥20 years of age.

• Subjects must meet all of the following criteria;

1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL

2. %TG change between Visit 2 and Visit 3 must be within 30%

3. %LDL-C change between Visit 2 and Visit 3 must be within 25%

Key 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-II deficiency or familial dysbetalipoproteinemia.

• Current or history of pancreatitis.

• Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.