Status:
COMPLETED
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Lead Sponsor:
Abbott
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives wer...
Detailed Description
This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.
Eligibility Criteria
Inclusion
- Baseline fasting serum TG level \> 200mg/dL and \<1000mg/dL, in subjects treated for HTG.
- 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
- Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04756180
Start Date
October 1 2016
End Date
April 1 2019
Last Update
March 5 2021
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