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Completed Phase 3 Interventional Results available

A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)

ClinicalTrials.gov ID: NCT00500149

Public ClinicalTrials.gov record NCT00500149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00500149
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
129 participants

Conditions and interventions

Conditions

Eligibility (public fields only)

Age range
6 Years to 12 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2007
Primary completion
Dec 4, 2007
Completion
Dec 4, 2007
Last update posted
Jun 13, 2021

2007

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
8
Facility City State ZIP Site status
Clinical Study Centers, LLC Little Rock Arkansas
Univ. of CA, Irvine Child Development Center Irvine California
Shire Clinical Research Site Wildomar California
Vince and Associates Clinical Research Overland Park Kansas
Center for Psychiatry & Behavioral Medicine Inc Las Vegas Nevada
Duke Child & Family Study Center Durham North Carolina
Duke University Medical Center Durham North Carolina
Shire Clinical Research Site Houston Texas
Shire Clinical Research Site Lubbock Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00500149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 13, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00500149 live on ClinicalTrials.gov.

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