NCT00191035已完成4 期
Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 21
- 主要终点
- Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks
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
- 13 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have ADHD.
- •Must be 13-16 years of age.
- •Must be able to swallow capsules.
- •Expected to achieve score of 70 or more on IQ test
- •Willing and reliable to keep appts. for clinic visits and test
排除标准
- •Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
- •Patients who weigh less than 40 kg or greater than 70 kg.
- •Patients with documented history of Bipolar I or II disorder, or psychosis
- •Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder
结局指标
主要结局
Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv
次要结局
- Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks
研究者
研究点 (21)
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