NCT00568685已完成3 期
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric 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
- 153
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score
研究概览
简要总结
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.
- •Patients must have ADHD, based on the accepted criteria for that disease
- •Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made
- •Patients must be able to swallow capsules
- •Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations
排除标准
- •Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency
- •Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment
- •Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk
- •Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure
研究组 & 干预措施
Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)
Active Comparator
干预措施: Atomoxetine hydrochloride (Drug)
Atomoxetine 0.5 mg/kg/day
Active Comparator
干预措施: Atomoxetine hydrochloride (Drug)
Atomoxetine 1.2 mg/kg/day
Active Comparator
干预措施: Atomoxetine hydrochloride (Drug)
结局指标
主要结局
Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score
时间窗: Baseline, Day 42
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).
次要结局
- Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint(Baseline, Days 7, 14, 42)
- Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint(Baseline, Days 7, 14, 42)
- Adverse Events Leading to Discontinuation(Baseline to Day 42)
- Temperature Change From Baseline to Day 42 Endpoint(Baseline, Day 42)
- Blood Pressure Change From Baseline to Day 42 Endpoint(Baseline, Day 42)
- Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary(Baseline to Day 42)
- Heart Rate Change From Baseline to Day 42 Endpoint(Baseline, Day 42)
- Weight Change From Baseline to Day 42 Endpoint(Baseline, Day 42)
研究者
研究点 (1)
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