A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 or ADHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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)

• 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 is not functioning at an age-appropriate level intellectually

• 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