Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
383 participants
INTERVENTIONAL
2015-06-10
2017-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AZD0585 2g group
AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
AZD0585
1g soft capsule
AZD0585 placebo
1g soft capsule
AZD0585 4g group
AZD0585 1g × 4 capsules once daily
AZD0585
1g soft capsule
Placebo control group
AZD0585 placebo 1g × 4 capsules once daily
AZD0585 placebo
1g soft capsule
Interventions
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AZD0585
1g soft capsule
AZD0585 placebo
1g soft capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%
Exclusion Criteria
* 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.
20 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kayoko Ikeda, MD
Role: PRINCIPAL_INVESTIGATOR
Social medial corporation Koyokai Nakajima Hospital
Locations
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Research Site
Aki-gun, , Japan
Research Site
Chiba, , Japan
Research Site
Chofu-shi, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukuyama-shi, , Japan
Research Site
Funabashi-shi, , Japan
Research Site
Gifu, , Japan
Research Site
Itami-shi, , Japan
Research Site
Kanazawa, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Koga-shi, , Japan
Research Site
Komatsu-shi, , Japan
Research Site
Nagoya, , Japan
Research Site
Naha, , Japan
Research Site
Niigata, , Japan
Research Site
Ōta-ku, , Japan
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Shinagawa-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Takamatsu, , Japan
Research Site
Takamatsu, , Japan
Research Site
Toyonaka-shi, , Japan
Research Site
Urasoe-shi, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D5884C00002
Identifier Type: -
Identifier Source: org_study_id
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