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

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

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.

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.

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.