Status:
COMPLETED
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00443391
Start Date
February 1 2007
End Date
October 1 2008
Last Update
January 18 2013
Active Locations (21)
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1
Site Reference ID/Investigator# 6109
Mesa, Arizona, United States, 85210
2
Site Reference ID/Investigator# 6765
Mesa, Arizona, United States, 85210
3
Site Reference ID/Investigator# 6100
Lafayette, California, United States, 94549
4
Site Reference ID/Investigator# 6107
San Diego, California, United States, 92103-8620