A phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, forced-dose titration, safety and efficacy study of lisdexamfetamine dimesylate (LDX) in adolescents aged 13-17 with attention deficit/hyperactivity disorder (ADHD)
Phase of Trial: Phase III
Latest Information Update: 23 Mar 2017
At a glance
- Drugs Lisdexamfetamine (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Shire
- 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 700013304, according to a Shire media release.
- 15 Nov 2010 Vyvanse approved by the FDA for the treatment of ADHD in adolescents aged 13-17 years, based on the resutls of this study, according to a Shire media release.
- 22 May 2010 Primary endpoint 'Attention Deficit Hyperactivity Disorder Rating Scale' has been met.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History