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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 248
- 主要终点
- Percent change in fasting serum TG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Double Blinded
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Omacor
Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
干预措施: Omega-3-acid ethyl ester or Placebo (Drug)
Placebo
Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
干预措施: Omega-3-acid ethyl ester or Placebo (Drug)
结局指标
主要结局
Percent change in fasting serum TG
时间窗: Baseline to end of treatment at treatment week 12
Percent change from baseline in fasting serum TG
次要结局
- Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio(Between baseline and end of treatment week 12)