NCT00095043已完成3 期
A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly 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
- 320
- 主要终点
- Safety and tolerability after 12 months of treatment
研究概览
简要总结
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.
详细描述
The duration of treatment is 1 year.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Insomnia
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability after 12 months of treatment
次要结局
- Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
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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An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)InsomniaNCT00103818H. Lundbeck A/S900
已完成
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Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)InsomniaNCT00102167H. Lundbeck A/S663
终止
3 期
Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)Primary InsomniaNCT00094666H. Lundbeck A/S465
撤回
3 期
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)InsomniaNCT00102154H. Lundbeck A/S