A Phase 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD).

Trial Profile

A Phase 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD).

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2018

At a glance

  • Drugs Guanfacine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus 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
    • 20 Sep 2016 Results of pooled post hoc analysis of this and other trial (NCT01244490) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
    • 01 Nov 2015 Primary endpoint has been met. (Attention-Deficit Hyperactivity Disorder Rating Scale), as per an article published in the Journal of the American Academy of Child and Adolescent Psychiatry
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