NCT00533676已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by 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
- 165
- 主要终点
- To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
研究概览
简要总结
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
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
- •Patients must be male or female between 18 to 70 years
- •Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control
排除标准
- •You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
- •You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
- •You are sensitive to niacin
- •You have a history gout
- •You drink more than 2 glasses of alcohol per day and you are not willing to stop
- •You don't have access to a telephone
结局指标
主要结局
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
时间窗: 8 weeks
次要结局
- To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.(8 weeks)
研究者
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