A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2011

At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors New River Pharmaceuticals
  • Most Recent Events

    • 02 Feb 2011 Health Canada approved lisdexamfetamine dimesylate capsules for the treatment of ADHD in adolescents and adults based on data from this trial and trial profile 700036858, according to a Shire media release.
    • 01 Sep 2008 Results have been published in the Journal of Clinical Psychiatry 69: 1364-1373, No. 9, Sep 2008. Primary endpoint comment added.
    • 03 May 2008 Results were presented at the 161st Annual Meeting of the American Psychiatric Association.
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