NCT00528697

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	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.
DRUG	atomoxetine	Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
DRUG	placebo	Subject will take a tablet once daily for 8 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-09-12
• Last updated: 2013-01-29

Locations

20 sites across 1 country: United States