NCT00191295已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 24
- 主要终点
- Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored
研究概览
简要总结
Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are diagnosed with ADHD
- •Patients must be able to swallow capsules
- •Patients must be of normal intelligence
排除标准
- •Patients who weigh less than 15 kg or more than 75 kg
- •Patients with organic brain disease (for example, dementia or traumatic brain injury residual)
结局指标
主要结局
Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored
次要结局
- Relationship between atomoxetine doses and both efficacy and safety variables
- Plasma concentration of atomoxetine and its metabolites
- Changes on ADHD RS-IV-J-School Version score
研究者
研究点 (24)
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