At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 549 enrolled
Drug / intervention
Lisdexamfetamine dimesylate +2 moredrug
Likely dose
Lisdexamfetamine dimesylate 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, and 1 other intervention for Attention-deficit/Hyperactivity Disorder. Completed, enrolled 549 participants across 95 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-deficit/Hyperactivity Disorder
CountriesCanada, Germany, Hungary, Sweden, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionMay 2014
TodayJul 2026
First PostedMar 13, 2012
Enrollment StartApr 3, 2012
Primary CompletionMay 22, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.3 years ago
Interventions
Lisdexamfetamine dimesylatedrug
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
Methylphenidate Hydrochloridedrug
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
Placebodrug
Daily oral dosing in the AM for 6 weeks