NCT00452179已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia
Arena Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2007年2月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Conventional PSG parameters
研究概览
简要总结
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
- •PSQI >/= to 5
- •Qualifying screening PSG parameters
- •Generally good health
排除标准
- •History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
- •Any clinically significant medical condition, laboratory finding, or ECG finding
- •Pregnant and/or lactating females
- •History of substance abuse within 2 years or positive urine drug screen
- •Positive Hepatitis B/C results or HIV markers
- •Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG
- •History of treatment with an investigational drug within the last month
- •Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study
结局指标
主要结局
Conventional PSG parameters
次要结局
- Patient reported subjective sleep parameters
研究者
研究点 (1)
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