CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 464 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.

Search/NCT01552915
NCT01552915Phase 4Completed
CompareCT.gov

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 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Mar 13, 2012·Updated Jun 8, 2021

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, and 1 other intervention for Attention-deficit/Hyperactivity Disorder. Completed, enrolled 464 participants across 79 sites.

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
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2012
Enrollment StartApr 17, 2012
Primary CompletionJan 22, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago

Interventions

Lisdexamfetamine dimesylatedrug

Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance

Methylphenidate Hydrochloridedrug

Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance

Placebodrug

Daily oral dosing in the AM for 8 weeks