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A multicenter double-blind, randomized, placebo-controlled, parallel-group study with three fixed doses of aripiprazole in the treatment of children and adolescents with autistic disorder (AD)

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Trial Profile

A multicenter double-blind, randomized, placebo-controlled, parallel-group study with three fixed doses of aripiprazole in the treatment of children and adolescents with autistic disorder (AD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2013

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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

    • 21 Nov 2009 Based on data from this and another phase III study (CTP 700015397), the U.S. FDA has approved aripiprazole for the treatment of irritability associated with autistic disorder in paediatric patients (ages 6 to 17 years).
    • 01 Oct 2009 Results published in the Journal of the American Academy of Child and Adolescent Psychiatry.
    • 18 May 2009 Results presented at the 162nd Annual Meeting of the American Psychiatric Association (APA 2009).

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