Date: 2012-03-06
Type of information: Initiation of the trial
phase: 4
Announcement: initiation of the trials
Company: Shire (UK-USA)
Product: Vyvanse® (lisdexamfetamine dimesylate)
Action
mechanism: lisdexamfetamine dimesylate is a chemically formulated long-acting, prodrug of dextroamphetamine, that belongs to the group of central nervous system stimulants.
Disease: Attention-Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial
details: The two Phase 4 clinical trials are randomized, double-blind, multi-center, parallel-group, active-controlled studies. They are designed to explore differences in efficacy between Vyvanse® and Concerta® in adolescents ages 13 to 17 with ADHD. This clinical trial program will utilize the clinician-administered ADHD-RS-IV Total Score to compare the efficacy of Vyvanse® to Concerta® . One trial will employ a dose optimization design and the other will employ a forced-dose titration schedule. Together the two trials will enroll approximately 1,000 patients, and results are expected by second half of 2013.
Latest
news: Shire announced it is initiating two Phase 4 clinical trials to compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII). Shire recently completed a Phase 3, 8-week double blind, dose-optimized, placebo-controlled study of Vyvanse® in the treatment of ADHD in children and adolescents in which Concerta was an active reference arm. Formal comparisons between Vyvanse® and Concerta® were not planned as part of that study. However, the data do suggest this as an area for further investigation. The data from this study have been presented previously at a major psychiatry meeting in late 2011. Last February, the FDA has approved Vyvanse® as a maintenance treatment for adults with ADHD.
