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

ADHD Clinical Trial

Official title:
A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity
Clinical Trial Details
NCT number NCT01274221
Study type Interventional
Source Takeda
Contact
Status Withdrawn
Phase Phase 3
Start date March 6, 2011
Completion date May 4, 2011
View Details
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