NCT01071291已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Niaspan™ on Reverse Cholesterol Transport in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Change from baseline in cholesterol efflux
研究概览
简要总结
This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male Subjects
- •Exclusion Criteria :
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
排除标准
- 未提供
研究组 & 干预措施
Arm A
Experimental
Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2
干预措施: Niaspan (Drug)
Arm B
Experimental
Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2
干预措施: Niaspan (Drug)
结局指标
主要结局
Change from baseline in cholesterol efflux
时间窗: Baseline and 12 weeks
Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)
时间窗: Baseline and 6 weeks
次要结局
未报告次要终点
研究者
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