NCT00533312已完成2 期
A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 407
- 主要终点
- To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
研究概览
简要总结
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between the ages of 18 and 70 years
- •Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant
排除标准
- •Patient has a history of peptic ulcer or gout
- •Patient is sensitive to niacin or products containing niacin
- •Patient drinks more than 2 alcoholic drinks per day
- •Patient has certain heart disease, cancer, or is HIV positive
结局指标
主要结局
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
时间窗: After 4 weeks
次要结局
- To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.(After 4 weeks)
研究者
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