An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
NCT ID: NCT04756180
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
248 participants
INTERVENTIONAL
2016-10-31
2019-04-30
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
NONE
Study Groups
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Omacor
Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Omega-3-acid ethyl ester or Placebo
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Placebo
Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Omega-3-acid ethyl ester or Placebo
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Interventions
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Omega-3-acid ethyl ester or Placebo
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Eligibility Criteria
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Inclusion Criteria
* If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
* Able and willing to give written informed consent.
Exclusion Criteria
* Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
* Pregnant of lactating females.
* Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease.
* Significant hepatic disease.
* Significantly reduced renal function.
* Alcohol consumption \>30g for male and 20g for female daily.
* Concomitant use of other investigational drugs.
* Subject related to the investigator.
* Subject expected to be not compliant.
18 Years
70 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Pooi Lee Chin
Role: STUDY_DIRECTOR
Abbott
Other Identifiers
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PUFA3001
Identifier Type: -
Identifier Source: org_study_id
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