An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Phase 3
Completed
- Conditions
- Hypertriglyceridemia
- Interventions
- Drug: Omega-3-acid ethyl ester or Placebo
- Registration Number
- NCT04756180
- Lead Sponsor
- Abbott
- 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 were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
Inclusion Criteria
- 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.
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omacor Omega-3-acid ethyl ester or Placebo Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks Placebo Omega-3-acid ethyl ester or Placebo Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
- Primary Outcome Measures
Name Time Method Percent change in fasting serum TG Baseline to end of treatment at treatment week 12 Percent change from baseline in fasting serum TG
- Secondary Outcome Measures
Name Time Method Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio Between baseline and end of treatment week 12 Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio