A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 [guanfacine] in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).

Trial Profile

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 [guanfacine] in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jan 2016

At a glance

  • Drugs Guanfacine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire
  • Most Recent Events

    • 27 Jan 2016 According to a Shionogi media release, the company has submitted a New Drug Application of S-877503 in Japan for the treatment of attention deficit hyperactivity disorder in children.
    • 18 May 2011 Results presented at the 164th Annual Meeting of the American Psychiatric Association.
    • 29 Oct 2010 Results reported in a Shire media release.
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