drugset / Trial / NCT01274221

Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01274221

Phase 3 Withdrawn Shire
RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.

Timeline

Start
2011-03-06
Primary completion
2011-05-04
Completion
2011-05-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lisdexamfetamine Dimesylate Small molecule