A multicenter double-blind, randomized, placebo-controlled, flexible-dosed, parallel-group study of aripiprazole flexibly dosed in the treatment of children and adolescents with autistic disorder (AD)
Phase of Trial: Phase III
Latest Information Update: 12 Apr 2017
At a glance
- Drugs Aripiprazole (Primary)
- Indications Autistic disorder
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Bristol-Myers Squibb; Otsuka Pharmaceutical Development & Commercialization
- 01 Dec 2009 Results were published in Pediatrics.
- 01 Dec 2009 Primary endpoint 'Aberrant Behavior Checklist' has been met.
- 21 Nov 2009 Based on data from this and another phase III study (CTP 700016586), the U.S. FDA has approved aripiprazole for the treatment of irritability associated with autistic disorder in paediatric patients (ages 6 to 17 years).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History