At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 129 enrolled
Drug / intervention
Vyvanse (lisdexamfetamine dimesylate) +1 moredrug
Likely dose
Vyvanse (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 IIIb, Randomized, Double-Blind, Multi-Center, Placebo- Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating Vyvanse (lisdexamfetamine dimesylate) and Placebo for ADHD. Completed, enrolled 129 participants across 9 sites.
Detailed Summary
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJul 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedJul 12, 2007
Enrollment StartJun 13, 2007
Primary CompletionDec 5, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.0 years ago
Interventions
Vyvanse (lisdexamfetamine dimesylate)drug
Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day).
Placebodrug
Placebo