NCT00554385终止2 期
The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 283
- 试验地点
- 23
- 主要终点
- ADHD-RS-IV (HV)
研究概览
简要总结
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
- •If female, subject must be practicing at least one method of birth control throughout the study.
- •If female, the result of a pregnancy test is negative.
- •The subject is judged to be in generally good health.
排除标准
- •The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
- •The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
- •The subject has a positive urine drug screen for alcohol or drugs of abuse.
- •The subject anticipates a move outside the geographic area.
研究组 & 干预措施
1
Experimental
干预措施: ABT-089 (Drug)
结局指标
主要结局
ADHD-RS-IV (HV)
时间窗: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
CGI-ADHD-S
时间窗: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
次要结局
未报告次要终点
研究者
研究点 (23)
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