Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00640419
Last Updated: 2013-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2008-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
2
ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
3
placebo
Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.
Interventions
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ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
placebo
Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.
Eligibility Criteria
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Inclusion Criteria
* Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s).
* Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
* Subject weights at least 37 pounds (17 kg)
* Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
Exclusion Criteria
* Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
* Subject has a history of, or ongoing, serious medical problem.
* Subject has a history of significant allergic reaction to any drug.
* Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
* Subject requires ongoing treatment with any psychiatric medication.
6 Years
12 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Gault
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 7536
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 7954
Bradenton, Florida, United States
Site Reference ID/Investigator# 7543
Jacksonville, Florida, United States
Site Reference ID/Investigator# 7542
Orlando, Florida, United States
Site Reference ID/Investigator# 7537
Libertyville, Illinois, United States
Site Reference ID/Investigator# 7561
Overland Park, Kansas, United States
Site Reference ID/Investigator# 7560
Troy, Michigan, United States
Site Reference ID/Investigator# 7559
Omaha, Nebraska, United States
Site Reference ID/Investigator# 7541
Las Vegas, Nevada, United States
Site Reference ID/Investigator# 7564
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 7538
Portland, Oregon, United States
Site Reference ID/Investigator# 7540
Memphis, Tennessee, United States
Site Reference ID/Investigator# 7544
Bellevue, Washington, United States
Countries
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References
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Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.
Other Identifiers
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M10-345
Identifier Type: -
Identifier Source: org_study_id
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