NCT00365859

Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Conditions

• Autistic Disorder
• Behavioral Symptoms

Interventions

Type	Name	Description
DRUG	Aripiprazole	Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-08-18
• Last updated: 2013-12-02
• Results posted: 2010-01-25

Locations

55 sites across 1 country: United States