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A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

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Trial Profile

A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2021

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At a glance

  • Drugs Guanfacine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Registrational
  • Sponsors Shire

    • Most Recent Events

    • 20 Sep 2016 Results of long-term growth-related safety outcomes presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
    • 12 Nov 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 21 Sep 2015 According to a Shire media release, the European Commission has granted Marketing Authorisation for once-daily, non-stimulant INTUNIV for the treatment of attention deficit hyperactivity disorder in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective
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