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SPD489-405: A Phase 4, Randomized, Double-Blind, Multicenter, Parallel Group, Active-Controlled, Dose-Optimization Safety and Efficacy Study of SPD489 (VYVANSE) Compared with OROS-MPH (CONCERTA) with a Placebo Reference Arm, in Adolescents Aged 13-17 Year
This study aims to evaluate the efficacy, safety, and tolerability of VYVANSE compared with CONCERTA in adolescents (13-17 years of age, inclusive) with ADHD. The study will have 3 phases 1) Screening and Washout; 2) Double-blind Evaluation of VYVANSE, CONCERTA and placebo, including Dose Optimization and Dose Maintenance Periods; and 3) Follow-up. The participants will be expected to come to the site for up to 10 visits over a 13 week period. During those visits the participants will undergo physical and medical exams, blood draws, urine test, ECGs, as well as psychiatric evaluations and behavioral assessments.