Status:
COMPLETED
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).
Eligibility Criteria
Inclusion
- Have voluntarily signed an informed consent form.
- 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
- Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00640419
Start Date
March 1 2008
End Date
July 1 2008
Last Update
January 18 2013
Active Locations (13)
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1
Site Reference ID/Investigator# 7536
Little Rock, Arkansas, United States, 72205
2
Site Reference ID/Investigator# 7954
Bradenton, Florida, United States, 34208
3
Site Reference ID/Investigator# 7543
Jacksonville, Florida, United States, 32216
4
Site Reference ID/Investigator# 7542
Orlando, Florida, United States, 32806