An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Omega-3-acid ethyl ester or Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omacor<br>Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks | Drug: Omega-3-acid ethyl ester or Placebo<br>* Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week<br>|
| Placebo Comparator: Placebo<br>Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks | Drug: Omega-3-acid ethyl ester or Placebo<br>* Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in fasting serum TG | Percent change from baseline in fasting serum TG | Baseline to end of treatment at treatment week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio | Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio | Between baseline and end of treatment week 12 |