NCT00485459已完成3 期
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
研究概览
简要总结
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with 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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
- •Subjects must be aged 6 to 16 years
- •Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
- •Subjects must be able to swallow capsules
- •Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
排除标准
- •Weigh less than 20 kg or more than 60 kg at study entry
- •Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- •Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
- •Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
- •Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
结局指标
主要结局
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
次要结局
- Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
- Compare the reduction in school-related symptoms between atomoxetine and placebo
- Assess the safety and tolerability of once-daily dosing of atomoxetine
研究者
研究点 (1)
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