NCT00191737已完成3 期
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
研究概览
简要总结
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday
- •Diagnosis of ADHD
- •Normal intelligence
排除标准
- •Weigh less than 30 kg or more than 85 kg at study entry
- •Other relevant psychiatric diagnoses
- •Are at serious suicidal risk as determined by the investigator
- •Have a history of severe allergies
- •Alcohol or drug abuse within the past 3 months
- •Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.
结局指标
主要结局
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
次要结局
- Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment
- Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment
研究者
研究点 (2)
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