NCT00536237已完成2 期
Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- To determine the effect of MK0524A on lipids and blood glucose
研究概览
简要总结
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.
Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
- •Must be willing to complete electronic diary
排除标准
- •Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
- •You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
- •You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
结局指标
主要结局
To determine the effect of MK0524A on lipids and blood glucose
时间窗: 17 Weeks
次要结局
- To establish the dose for limiting flushing symptoms induced by NIASPAN (R)(17 Weeks)
研究者
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