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Completed

NCT Number: NCT02463071

AZD0585 Phase III Long-term Study in Japan

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 .

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aki-gun, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Japanese men or women, ≥20 years of age.
  • Subjects must meet all of the following criteria;
  • Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL
  • %TG change between Visit 2 and Visit 3 must be within 30%
  • %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.

Treatment and study plan

AZD0585

Drug

1g soft capsule

Other names: Epanova

AZD0585 placebo

Drug

1g soft capsule

Other names: Corn oil

Primary outcomes

  1. Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides

    Time frame: From baseline to Week12

    To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.

  2. Safety of AZD0585 by Assessment of Adverse Events in Patients

    Time frame: From baseline to Week52

    To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.

Secondary outcomes

  1. Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile

    Time frame: From baseline to Week12

    To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol.

  2. Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.

    Time frame: From baseline to Week12

    To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate.

  3. Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile

    Time frame: From baseline to Week12

    To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E.

  4. Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio

    Time frame: From baseline to Week12

    To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).

  5. Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP

    Time frame: From baseline to Week12

    To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Oct 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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