NCT01097382已完成4 期
National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
研究概览
简要总结
Primary Objective:
To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration
Secondary Objective:
To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AMBIEN CR
Experimental
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
干预措施: ZOLPIDEM (Drug)
结局指标
主要结局
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
时间窗: at Baseline, at V2 (26 +/- 2 days)
次要结局
- Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)(at Baseline, at V2 (26 +/- 2 days))
研究者
研究点 (6)
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