AZD0585 Phase III Long-term Study in Japan

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: AZD0585; Drug: AZD0585 placebo

• Registration Number: NCT02463071
• Lead Sponsor: AstraZeneca

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Study Start: 2015-06-10
• Primary Completion: 2017-03-11
• Study Completion: 2017-03-11
• Status Verified: 2018-02
• Results First Submitted: 2018-02-02
• Results First Submitted QC: 2018-02-02
• Last Update Submitted: 2018-02-02
• Results First Posted: 2018-10-01
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD0585 2g group	AZD0585 placebo	AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
AZD0585 4g group	AZD0585	AZD0585 1g × 4 capsules once daily
Placebo control group	AZD0585 placebo	AZD0585 placebo 1g × 4 capsules once daily
AZD0585 2g group	AZD0585	AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily

Primary Outcome Measures

Name	Time	Method
Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides	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.
Safety of AZD0585 by Assessment of Adverse Events in Patients	From baseline to Week52	To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.

Secondary Outcome Measures

Name	Time	Method
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio	From baseline to Week12	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile	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.
Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile	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.
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.	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.
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP	From baseline to Week12	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).

Trial Locations

Locations (1)

Research Site; 🇯🇵 Urasoe-shi, Japan