A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00554385
Last Updated: 2011-08-23
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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TERMINATED
PHASE2
283 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
Interventions
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ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
12 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Gault, M.D., Ph.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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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
Site Ref #/Investigator 6856
Las Vegas, Nevada, United States
Site Ref #/Investigator 6683
Clementon, New Jersey, United States
Site Ref #/Investigator 8297
Oklahoma City, Oklahoma, United States
Site Ref #/Investigator 6682
Eugene, Oregon, United States
Site Ref #/Investigator 6811
Portland, Oregon, United States
Site Ref #/Investigator 8701
Portland, Oregon, United States
Site Ref #/Investigator 6681
Salem, Oregon, United States
Site Ref #/Investigator 6799
Charleston, South Carolina, United States
Site Ref #/Investigator 7955
Memphis, Tennessee, United States
Site Ref #/Investigator 6836
Austin, Texas, United States
Site Ref #/Investigator 6835
Herndon, Virginia, United States
Site Ref #/Investigator 6791
Bellevue, Washington, United States
Site Ref #/Investigator 6838
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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M10-178
Identifier Type: -
Identifier Source: org_study_id
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