NCT01617447

A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Placebo of Aripiprazole	administered orally once daily
DRUG	Aripiprazole	Flexibly dose administered orally once daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-06-12
• Last updated: 2017-04-11
• Results posted: 2017-04-11

Locations

5 sites across 1 country: Japan