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临床试验/NCT00533312
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)

Merck Sharp & Dohme LLC0 个研究点目标入组 407 人开始时间: 2005年4月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

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