A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00528697
Last Updated: 2013-01-29
Study Results
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Basic Information
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COMPLETED
PHASE2
278 participants
INTERVENTIONAL
2007-09-30
2008-04-30
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
Lowest ABT-089 dose
ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
2
Low-medium ABT-089 dose
ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
3
Medium-high ABT-089 dose
ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
4
Highest ABT-089 dose
ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
5
atomoxetine
atomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
6
placebo
placebo
Subject will take a tablet once daily for 8 weeks
Interventions
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ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
atomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
placebo
Subject will take a tablet once daily for 8 weeks
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)
* First grade or higher in a school setting 3 days/week
* Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
* Subject weighs at least 37 pounds (17 kg)
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
* Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations
Exclusion Criteria
* Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
* Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
* Subject has a history of significant allergic reaction to any drug
* Subject requires ongoing treatment with any psychiatric medication
* Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence
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, MD, PhD, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 5999
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 5979
El Centro, California, United States
Site Reference ID/Investigator# 5986
Boulder, Colorado, United States
Site Reference ID/Investigator# 5993
Bradenton, Florida, United States
Site Reference ID/Investigator# 5995
Jacksonville, Florida, United States
Site Reference ID/Investigator# 5977
Orlando, Florida, United States
Site Reference ID/Investigator# 5981
Northbrook, Illinois, United States
Site Reference ID/Investigator# 5982
Overland Park, Kansas, United States
Site Reference ID/Investigator# 5992
Omaha, Nebraska, United States
Site Reference ID/Investigator# 5997
Las Vegas, Nevada, United States
Site Reference ID/Investigator# 5987
Clementon, New Jersey, United States
Site Reference ID/Investigator# 5996
Eugene, Oregon, United States
Site Reference ID/Investigator# 5984
Portland, Oregon, United States
Site Reference ID/Investigator# 5980
Salem, Oregon, United States
Site Reference ID/Investigator# 5994
Charleston, South Carolina, United States
Site Reference ID/Investigator# 5976
Memphis, Tennessee, United States
Site Reference ID/Investigator# 6000
Austin, Texas, United States
Site Reference ID/Investigator# 5998
Herndon, Virginia, United States
Site Reference ID/Investigator# 5978
Bellevue, Washington, United States
Site Reference ID/Investigator# 5983
Middleton, Wisconsin, 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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M06-888
Identifier Type: -
Identifier Source: org_study_id
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