NCT01180764撤回4 期
Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- HDL Composition
研究概览
简要总结
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.
Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.
Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lovaza
Experimental
Lovaza 4g po qd
干预措施: Lovaza (Omega-3 acid ethyl esters) (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
HDL Composition
时间窗: 12 weeks
HDL composition (protein and lipid) by size (gel filtration column)
次要结局
- HDL cholesterol composition by density subfraction(12 weeks)
- Safety(12 weeks)
研究者
研究点 (1)
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