A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

Trial Profile

A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

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

    • 20 Sep 2016 Results of pooled post hoc analysis of this and other trial (NCT01081132) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
    • 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
    • 25 Apr 2013 Planned end date changed from 1 Jun 2013 to 1 May 2013 as reported by ClinicalTrials.gov.
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