NCT00562055撤回2 期
Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Adult ADHD Investigator Symptom Rating Scale - Total Score
研究概览
简要总结
This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity 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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
- •Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
- •Score of 4 or higher on the Clinician Global Impression - Severity scale
排除标准
- •Significant comorbid psychiatric diagnoses
- •Significant risk of suicidal or violent behavior
研究组 & 干预措施
Arm A
Experimental
干预措施: PNU-165442G; [S,S]-reboxetine (Drug)
Arm B
Active Comparator
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Adult ADHD Investigator Symptom Rating Scale - Total Score
时间窗: 4 weeks
次要结局
- Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score(4 weeks)
- Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score(4 weeks)
研究者
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