NCT00116519已完成2 期
PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 55
- 主要终点
- Effects on HDL-C and Triglycerides after 12 weeks
研究概览
简要总结
The purposes of this study are to determine:
- The safety of the study medication and any side effects that might be associated with it;
- Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
- How much of the study medication should be given to patients;
- How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 80 years of age
- •People with abnormal fat levels in the blood (low HDL, high TG)
排除标准
- •People with diabetes
- •People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
- •People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months
结局指标
主要结局
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks
次要结局
- Effects on factors of metabolic syndrome after 12 weeks
- Effects on biomarkers of atherosclerosis after 12 weeks
- Effects on LDL-C after 12 weeks
研究者
研究点 (55)
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