NCT01047683已完成3 期
Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
研究概览
简要总结
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages >18
- •Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
- •Provide written informed consent and authorization for protected health information disclosure
排除标准
- •Women who are pregnant or lactating, or planning to become pregnant
- •Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
- •History of pancreatitis
- •History of bariatric surgery or currently on weight loss drugs
- •Uncontrolled hypertension (BP > 160/100)
- •HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
- •Consumption of more than 2 alcoholic beverages per day
- •History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer)
- •Participation in another clinical trial involving an investigational agent in the last 30 days
- •Other parameters will be assessed at the study center to ensure eligibility for this study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
AMR101 (ethyl icosapentate) - 2 g/day
Experimental
干预措施: AMR101 (ethyl icosapentate) - 2 g/day (Drug)
AMR101 (ethyl icosapentate) - 4 g/day
Experimental
干预措施: AMR101 (ethyl icosapentate) - 4 g/day (Drug)
结局指标
主要结局
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
时间窗: baseline and 12 weeks
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
次要结局
- Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels(baseline and 12 weeks)
- Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels(baseline and 12 weeks)
- Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels(baseline and 12 weeks)
研究者
研究点 (1)
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