NCT00103818已完成3 期
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 主要终点
- Patient-reported amount of sleep and time to fall asleep at night after 3 months
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).
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 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients who are between the ages of 18 and 64
排除标准
- •Adults who do not have a diagnosis of insomnia (a sleep disorder)
结局指标
主要结局
Patient-reported amount of sleep and time to fall asleep at night after 3 months
时间窗: After 3 months
次要结局
- Patient-reported awakenings at night(After 3 months)
- Functioning after 3 months(After 3 months)
- Sleep quality(After 3 months)
研究者
相似试验
已完成
3 期
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)InsomniaNCT00095069H. Lundbeck A/S600
已完成
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Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)InsomniaNCT00095043H. Lundbeck A/S320
终止
2 期
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)Primary InsomniaNCT00266357H. Lundbeck A/S50
已完成
2 期
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)Primary InsomniaNCT00266344H. Lundbeck A/S520
撤回
3 期
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)InsomniaNCT00102154H. Lundbeck A/S
