NCT00443391已完成2 期
The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study
AbbVie (prior sponsor, Abbott)21 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2007年2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
- 141
- 试验地点
- 21
- 主要终点
- CAARS:INV
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 adults 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
- •If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
- •If female, the result of a pregnancy tests are negative
- •The subject is judged to be in generally good health
排除标准
- •More than 7 days have elapsed since the last dose of study drug in Study M06-855
- •The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
- •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
CAARS:INV
时间窗: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
时间窗: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
次要结局
- AAQoL(Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24)
- WPAI(Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24)
- RUQ(Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24)
- FTND(Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24)
研究者
研究点 (21)
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