NCT00528697已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)
AbbVie (prior sponsor, Abbott)20 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 20
- 主要终点
- ADHD-RS-IV (HV) - Administered by study doctor
研究概览
简要总结
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have voluntarily signed an informed consent form
- •Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
- •First grade or higher in a school setting 3 days/week
- •Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
- •Subject weighs at least 37 pounds (17 kg)
- •Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
- •Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations
排除标准
- •Subject is not functioning at an age-appropriate level intellectually
- •Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
- •Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
- •Subject has a history of significant allergic reaction to any drug
- •Subject requires ongoing treatment with any psychiatric medication
- •Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence
研究组 & 干预措施
1
Experimental
Lowest ABT-089 dose
干预措施: ABT-089 (Drug)
2
Experimental
Low-medium ABT-089 dose
干预措施: ABT-089 (Drug)
3
Experimental
Medium-high ABT-089 dose
干预措施: ABT-089 (Drug)
4
Experimental
Highest ABT-089 dose
干预措施: ABT-089 (Drug)
5
Active Comparator
atomoxetine
干预措施: atomoxetine (Drug)
6
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
ADHD-RS-IV (HV) - Administered by study doctor
时间窗: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
次要结局
- Health Outcomes Measurements(Baseline to Final Evaluation of 8-week treatment period)
- Clinical Global Impression-ADHD-Severity Scale(Baseline to Final Evaluation of 8-week treatment period)
- Parent Rating Scales(Baseline to Final Evaluation of 8-week treatment period)
- Teacher Rating Scale(Baseline to Final Evaluation of 8-week treatment period)
研究者
研究点 (20)
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