A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Trial Profile

A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Jun 2015

At a glance

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

    • 12 Jun 2012 Results published in the Journal of Clinical Psychiatry.
    • 07 Feb 2012 Results from this trial supported US approval of lisdexamfetamine for maintenance treatment of adults with attention deficit hyperactivity disorder.
    • 18 May 2011 Primary endpoint 'Relapse-rate' has been met.
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