NCT00686933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 for Subjects Completing Study M10-346
AbbVie (prior sponsor, Abbott)12 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2008年5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
- 117
- 试验地点
- 12
- 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 effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (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 M10-346 and completed the study.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- •Male subjects must agree to comply with applicable contraceptive requirements.
- •The subject is judged to be in generally good health.
排除标准
- •The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
时间窗: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
次要结局
- CAARS:Self(Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24)
- BRIEF-A(Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24)
- AAQOL(Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24)
- WPAI(Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24)
- FTND(Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
2 期
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity DisorderNCT00443391AbbVie (prior sponsor, Abbott)141
终止
2 期
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00554385Abbott283
终止
2 期
A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 StudyAlzheimer's DiseaseNCT00809510Abbott63
终止
2 期
Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01690195AbbVie (prior sponsor, Abbott)343
终止
2 期
This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01676935AbbVie (prior sponsor, Abbott)349