NCT00191516已完成3 期
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children 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
- 257
- 试验地点
- 1
- 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 quality of sleep in children (aged 6 through 11 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
- 6 Years 至 11 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 6 years of age and who will not have reached their 12th birthday
- •Diagnosis of ADHD
- •Normal intelligence
排除标准
- •Weigh less than 20 kg or more than 60 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
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.
- O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity DisorderAttention Deficit Hyperactivity DisorderNCT00191737Eli Lilly and Company147
已完成
3 期
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in ChinaParoxysmal Nocturnal HemoglobinuriaNCT05886244Alexion Pharmaceuticals, Inc.25
终止
3 期
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the KneeOsteoarthritis of the KneeNCT04931667Biosplice Therapeutics, Inc.73
已完成
3 期
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast CancerBreast NeoplasmsNCT01572038Hoffmann-La Roche1,436
已完成
3 期
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)Primary IgA NephropathyNCT04541043Calliditas Therapeutics AB119