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)

Trial Profile

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)

Completed
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
  • Most Recent Events

    • 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).
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