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AZD0585 Phase III Long-term Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02463071
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: AZD0585 Drug: AZD0585 placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : March 11, 2017
Actual Study Completion Date : March 11, 2017

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 Name: Epanova

Drug: AZD0585 placebo
1g soft capsule
Other Name: Corn oil

Experimental: AZD0585 4g group
AZD0585 1g × 4 capsules once daily
Drug: AZD0585
1g soft capsule
Other Name: Epanova

Placebo Comparator: Placebo control group
AZD0585 placebo 1g × 4 capsules once daily
Drug: AZD0585 placebo
1g soft capsule
Other Name: Corn oil




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463071


Locations
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Japan
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Kayoko Ikeda, MD Social medial corporation Koyokai Nakajima Hospital
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] April 3, 2015
Statistical Analysis Plan  [PDF] September 19, 2016

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02463071    
Other Study ID Numbers: D5884C00002
First Posted: June 4, 2015    Key Record Dates
Results First Posted: October 1, 2018
Last Update Posted: October 1, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases