NCT00191048已完成4 期
Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ADHD only or ADHD and Dyslexia
- •At least 10 years old and no more than 16 years old
- •IQ score of 80 or more
- •Must be able to swallow capsules
排除标准
- •Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •Weigh less than 25 kg or greater than 70 kg
- •Pregnant or breast feeding
- •Documented history of bipolar I or II disorder, or psychosis
- •Documented history of autism, Asperger's syndrome or pervasive developmental disorder
结局指标
主要结局
To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv
次要结局
- To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.
研究者
研究点 (8)
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