NCT00092859已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 主要终点
- Body weight after 1 year of treatment. Safety and tolerability for 2 years.
研究概览
简要总结
This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study
排除标准
- •Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
结局指标
主要结局
Body weight after 1 year of treatment. Safety and tolerability for 2 years.
时间窗: After 1 & 2 years of treatment
次要结局
- Durability of weight loss over two years.(Over two years.)
研究者
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