NCT00536510已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 646
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
研究概览
简要总结
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
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 (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
- •Patient is male or female between 18 and 70 years of age
- •Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study
排除标准
- •Patient has a history of not being able to take niacin or niacin-containing products
- •Patient consumes more than 2 alcoholic beverages per day
- •Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
- •Patient engages in vigorous exercise or an aggressive diet regimen
研究组 & 干预措施
1
Experimental
laropiprant/niacin (MK0524A)
干预措施: laropiprant/niacin (MK0524A) (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
时间窗: 12 weeks
Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100
次要结局
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks(12 weeks)
研究者
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