NCT00640419已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of Children With Attention Deficit-Hyperactivity Disorder (ADHD)
AbbVie (prior sponsor, Abbott)13 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2008年3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
- 121
- 试验地点
- 13
- 主要终点
- ADHD-RS-IV (HV)
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 (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).
- •Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
- •Subject weights at least 37 pounds (17 kg)
- •Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- •Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
排除标准
- •Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
- •Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
- •Subject has a history of, or ongoing, serious medical problem.
- •Subject has a history of significant allergic reaction to any drug.
- •Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
- •Subject requires ongoing treatment with any psychiatric medication.
研究组 & 干预措施
1
Experimental
干预措施: ABT-089 (Drug)
2
Experimental
干预措施: ABT-089 (Drug)
3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
ADHD-RS-IV (HV)
时间窗: Screening, Day -1, Day 7, Day 14, Day 28, Day 42
次要结局
- CSHQ(Day-1, Day 28, Day 42)
- CGI-P(Day -1, Day 21, Day 42)
- BRIEF(Day -1, Day 28, Day 42)
- CGI-ADHD-S(Screening, Day -1, Day 7, Day 14, Day 28 and Day 42)
研究者
研究点 (13)
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