NCT00664664已完成2 期
A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep
Arena Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 744 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 744
- 试验地点
- 1
- 主要终点
- Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
研究概览
简要总结
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18 to 65 years
- •Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
- •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
- •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
研究组 & 干预措施
1
Experimental
APD125 20 mg
干预措施: APD125 (Drug)
2
Experimental
APD125 40 mg
干预措施: APD125 (Drug)
3
Placebo Comparator
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
时间窗: During and after 2 weeks of study drug
次要结局
- Change from baseline in subjective total sleep time (sTST)(During and after 2 weeks on study drug)
- Change from baseline in subjective wake time after sleep onset (sWASO)(During and after 2 weeks on study drug)
- Change in subjective latency to sleep onset (sSLO)(During and after 2 weeks on study drug)
- Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.(During and after 2 weeks on study drug)
研究者
研究点 (1)
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