A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE) Compared With OROS-MPH (CONCERTA) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Trial Profile

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE) Compared With OROS-MPH (CONCERTA) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Sep 2015

At a glance

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

    • 01 Sep 2015 Results of SPD489-405, SPD489-406 and SPD489-325 trials presented at the 28th Annual Congress of the European College of Neuropsychopharmacology.
    • 08 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrial.gov.
    • 24 Oct 2013 Planned end date changed from 1 Jul 2014 to 1 Mar 2014 as reported by ClinicalTrials.gov.
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