A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- Registration Number
- NCT00554385
- Lead Sponsor
- Abbott
- Brief Summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 283
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ABT-089 -
- Primary Outcome Measures
Name Time Method ADHD-RS-IV (HV) Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 CGI-ADHD-S Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Site Ref #/Investigator 6800
🇺🇸Little Rock, Arkansas, United States
Site Ref #/Investigator 6812
🇺🇸Boulder, Colorado, United States
Site Ref #/Investigator 8366
🇺🇸Bradenton, Florida, United States
Site Ref #/Investigator 6808
🇺🇸Jacksonville, Florida, United States
Site Ref #/Investigator 6827
🇺🇸Orlando, Florida, United States
Site Ref #/Investigator 8383
🇺🇸Libertyville, Illinois, United States
Site Ref #/Investigator 6802
🇺🇸Northbrook, Illinois, United States
Site Ref #/Investigator 6824
🇺🇸Overland Park, Kansas, United States
Site Ref #/Investigator 8428
🇺🇸Troy, Michigan, United States
Site Ref #/Investigator 6902
🇺🇸Omaha, Nebraska, United States
Scroll for more (13 remaining)Site Ref #/Investigator 6800🇺🇸Little Rock, Arkansas, United States