A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder.

Trial Profile

A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2016

At a glance

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

    • 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
    • 01 Jun 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 25 Apr 2013 Planned end date changed from 1 Jul 2013 to 1 Jun 2013 as reported by ClinicalTrials.gov.
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