NCT00485628已完成2 期
An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children 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
- 37
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.
研究概览
简要总结
Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 6 - 18 years of age
- •Patients must meet DSM-IV diagnostic criteria for ADHD
- •Patient must be able to swallow capsules
- •Patients must be of normal intelligence
- •Laboratory results must show no significant abnormalities
排除标准
- •Patients who weigh less than 15 kg or more than 75 kg at study entry
- •Patients who have a documented history of bipolar disorder or any history of psychosis
- •Patients taking any antipsychotic medication within 26 weeks of visit 1
- •Patients with a severe history of allergies
- •Patients taking methylphenidate
结局指标
主要结局
The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.
次要结局
- To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.
- To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine
研究者
研究点 (1)
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