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.
1 other identifier
interventional
383
1 country
26
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2015
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedStudy Start
First participant enrolled
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2017
CompletedResults Posted
Study results publicly available
October 1, 2018
CompletedOctober 1, 2018
February 1, 2018
1.8 years
June 3, 2015
February 2, 2018
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
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
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
From baseline to Week52
Secondary Outcomes (5)
Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
From baseline to Week12
Study Arms (3)
AZD0585 2g group
EXPERIMENTALAZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
AZD0585 4g group
EXPERIMENTALAZD0585 1g × 4 capsules once daily
Placebo control group
PLACEBO COMPARATORAZD0585 placebo 1g × 4 capsules once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
Research Site
Aki-gun, 735-0021, Japan
Research Site
Chiba, 261-0004, Japan
Research Site
Chofu-shi, 182-0006, Japan
Research Site
Fukuoka, 812-0027, Japan
Research Site
Fukuoka, 819-8551, Japan
Research Site
Fukuyama-shi, 721-0927, Japan
Research Site
Funabashi-shi, 273-0046, Japan
Research Site
Gifu, 500-8717, Japan
Research Site
Itami-shi, 664-0846, Japan
Research Site
Kanazawa, 921-8035, Japan
Research Site
Kawasaki-shi, 216-0006, Japan
Research Site
Koga-shi, 306-0232, Japan
Research Site
Komatsu-shi, 923-0861, Japan
Research Site
Nagoya, 457-0046, Japan
Research Site
Naha, 900-0032, Japan
Research Site
Niigata, 950-1104, Japan
Research Site
Ōta-ku, 144-0034, Japan
Research Site
Sendai, 981-0923, Japan
Research Site
Sendai, 983-0039, Japan
Research Site
Sendai, 983-0835, Japan
Research Site
Shinagawa-ku, 141-6003, Japan
Research Site
Shinjuku-ku, 160-0017, Japan
Research Site
Takamatsu, 760-0018, Japan
Research Site
Takamatsu, 760-0076, Japan
Research Site
Toyonaka-shi, 560-0082, Japan
Research Site
Urasoe-shi, 901-2132, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Torbjorn Lundstrom, MD, PhD
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Kayoko Ikeda, MD
Social medial corporation Koyokai Nakajima Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2015
First Posted
June 4, 2015
Study Start
June 10, 2015
Primary Completion
March 11, 2017
Study Completion
March 11, 2017
Last Updated
October 1, 2018
Results First Posted
October 1, 2018
Record last verified: 2018-02