Shire initiates Phase IV trials to compare Vyvanse ands Concerta

Shire will initiate two Phase IV clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta� (methylphenidate HCl) Extended-Release Tablets, (CII).e 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.