NCT00386581已完成3 期
Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
研究概览
简要总结
The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.
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
- Double
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have ADHD that meets the DSM-IV criteria
- •Aged 6 to 16 years.
- •Subjects must not have taken any medication used to treat ADHD.
- •Laboratory results must show no significant abnormalities
- •Baseline ECG results must not show an abnormality
- •Subjects must be able to swallow capsules.
- •Subjects must be of normal intelligence.
排除标准
- •Weigh less than 20 kg or more than 60 kg at study entry.
- •Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating.
- •Have a history of Bipolar I or II disorder, psychosis, or PDD.
- •Meet DSM-IV criteria for an anxiety disorder.
- •Have a history of any seizure disorder.
- •Patients at serious suicidal risk.
- •Patients with narrow angle glaucoma
- •Subjects who have a history of severe allergies .
- •Have a history of alcohol or drug abuse within the past 3 months
- •Screen positive for drugs of abuse not prescribed by a physician.
- •Have cardiovascular disease and an increased heart rate and blood pressure.
- •Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis.
- •Have severe gastrointestinal narrowing
- •Are during the study time likely to need psychotropic medications.
- •Are likely to begin a structured psychotherapy aimed at ADHD symptoms.
- •Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
- •Female subjects who are pregnant or who are breast-feeding.
- •Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
- •Are, in the opinion of the investigator, unsuitable in any other way to participate in this study.
- •Are employed by Lilly.
结局指标
主要结局
Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
次要结局
- To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners
- To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents
研究者
研究点 (1)
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