NCT01552902

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Conditions

• Attention-deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine dimesylate	Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
DRUG	Methylphenidate Hydrochloride	Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
DRUG	Placebo	Daily oral dosing in the AM for 6 weeks

Timeline

• Start date: 2012-04-03
• Primary completion: 2014-05-22
• Completion: 2014-05-22
• First posted: 2012-03-13
• Last updated: 2021-06-10
• Results posted: 2015-03-18

Locations

95 sites across 5 countries: United States, Canada, Germany, Hungary, Sweden