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A phase III, randomized, multi-center, double-blind, parallel-group, placebo-controlled safety and efficacy study of SPD503 [Intuniv; guanfacine] in children and adolescents aged 6-17 with attention-deficit/hyperactivity disorder (ADHD).

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Trial Profile

A phase III, randomized, multi-center, double-blind, parallel-group, placebo-controlled safety and efficacy study of SPD503 [Intuniv; guanfacine] in children and adolescents aged 6-17 with attention-deficit/hyperactivity disorder (ADHD).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2021

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At a glance

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

    • 29 Jul 2018 Results of post hoc analysis of four studies (SPD503-301, SPD503-304, SPD503-312 and SPD503-316) published in the European Neuropsychopharmacology
    • 07 May 2008 Results of a pooled analysis presented at APS 2008, according to a Shire media release.
    • 30 Jan 2008 Results have been published (1101050)
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