AZD0585 Phase III Long-term Study in Japan

A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase III 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.

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 .

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.