Clinical Trial: A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Brief Summary: The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Current Primary Outcome: Mean change from baseline at the final assessment in Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score [ Time Frame: Baseline, the final administration ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: June 8, 2012
Date Started: September 2012
Date Completion:
Last Updated: May 25, 2017
Last Verified: May 2017