NCT00191386已完成3 期
Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events for Long Term Safety and Tolerability
研究概览
简要总结
The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).
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 who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
- •Patients wish to enter into this study
排除标准
- •Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval
研究组 & 干预措施
Atomoxetine
Experimental
0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
干预措施: Atomoxetine hydrochloride (Drug)
结局指标
主要结局
Number of Participants With Adverse Events for Long Term Safety and Tolerability
时间窗: Baseline through 4 years
Details on the actual adverse events are presented in the Reported Adverse Events Section.
次要结局
- Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score(Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years)
- Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)(Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years)
- Cytochrome P450 2D6 (CYP2D6) Phenotype Status(Over 1 year)
研究者
研究点 (1)
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