CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 318 enrolled
Drug / intervention
Vyvanse (lisdexamfetamine dimesylate)drug
Likely dose
Vyvanse (lisdexamfetamine dimesylate) 20mgfrom 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/NCT00500071
NCT00500071Phase 4Completed

A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

Shire·interventional·Posted Jul 12, 2007·Updated Mar 10, 2022

In Brief

A Phase 4 clinical trial evaluating Vyvanse (lisdexamfetamine dimesylate) for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 318 participants across 46 sites.

Detailed Summary

Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2007
Enrollment StartJun 28, 2007
Primary CompletionJan 2, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.0 years ago

Interventions

Vyvanse (lisdexamfetamine dimesylate)drug

Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.