NCT01725646已完成3 期
A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Excelsior
- 入组人数
- 253
- 试验地点
- 4
- 主要终点
- Change in Triglycerides from baseline
研究概览
简要总结
- Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
- Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
详细描述
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL
排除标准
- •Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
- •Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization
研究组 & 干预措施
Omacor® 4 g
Active Comparator
Subjects in this group will take 4 g of Omacor® everyday.
干预措施: Omacor® (Drug)
Omacor® 2 g
Active Comparator
Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
干预措施: Omacor® (Drug)
Placebo
Placebo Comparator
Subjects in this group will take 4 g of placebo everyday.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Triglycerides from baseline
时间窗: baseline and 8 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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