AZD0585 Phase III Long-term Study in Japan

February 2, 2018 updated by: AstraZeneca

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aki-gun, Japan, 735-0021
        • Research Site
      • Chiba-shi, Japan, 261-0004
        • Research Site
      • Chofu-shi, Japan, 182-0006
        • Research Site
      • Fukuoka-shi, Japan, 812-0027
        • Research Site
      • Fukuoka-shi, Japan, 819-8551
        • Research Site
      • Fukuyama-shi, Japan, 721-0927
        • Research Site
      • Funabashi-shi, Japan, 273-0046
        • Research Site
      • Gifu-shi, Japan, 500-8717
        • Research Site
      • Itami-shi, Japan, 664-0846
        • Research Site
      • Kanazawa-shi, Japan, 921-8035
        • Research Site
      • Kawasaki-shi, Japan, 216-0006
        • Research Site
      • Koga-shi, Japan, 306-0232
        • Research Site
      • Komatsu-shi, Japan, 923-0861
        • Research Site
      • Nagoya-shi, Japan, 457-0046
        • Research Site
      • Naha-shi, Japan, 900-0032
        • Research Site
      • Niigata-shi, Japan, 950-1104
        • Research Site
      • Ota-ku, Japan, 144-0034
        • Research Site
      • Sendai-shi, Japan, 981-0923
        • Research Site
      • Sendai-shi, Japan, 983-0039
        • Research Site
      • Sendai-shi, Japan, 983-0835
        • Research Site
      • Shinagawa-ku, Japan, 141-6003
        • Research Site
      • Shinjuku-ku, Japan, 160-0017
        • Research Site
      • Takamatsu-shi, Japan, 760-0018
        • Research Site
      • Takamatsu-shi, Japan, 760-0076
        • Research Site
      • Toyonaka-shi, Japan, 560-0082
        • Research Site
      • Urasoe-shi, Japan, 901-2132
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD0585 2g group
AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
Drug: AZD0585
1g soft capsule
Other Names:
  • Epanova
Drug: AZD0585 placebo
1g soft capsule
Other Names:
  • Corn oil
Experimental: AZD0585 4g group
AZD0585 1g × 4 capsules once daily
Drug: AZD0585
1g soft capsule
Other Names:
  • Epanova
Placebo Comparator: Placebo control group
AZD0585 placebo 1g × 4 capsules once daily
Drug: AZD0585 placebo
1g soft capsule
Other Names:
  • Corn oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Week12
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.
From baseline to Week52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Week12
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.
From baseline to Week12
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.
From baseline to Week12
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).
From baseline to Week12
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).
From baseline to Week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Kayoko Ikeda, MD, Social medial corporation Koyokai Nakajima Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2015

Primary Completion (Actual)

March 11, 2017

Study Completion (Actual)

March 11, 2017

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5884C00002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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