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NCT00500071 · ClinicalTrials.gov registry record · Phase 4
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
A Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT00500071 is a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Shire. The registered enrollment target is 318 participants, above the 126-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT00500071, a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study Summary
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
Conditions Studied
Interventions
- DRUG Vyvanse (lisdexamfetamine dimesylate)
Study Locations (20)
Florida
- Sarkis Clinical Trials - Gainesville
- Shire Clinical Research Site - Hialeah
- CNS Research Institute, Inc - Jacksonville
- CORE Research, Inc - Maitland
- Miami Research Associates - Miami
- Clinical Neuroscience Solutions, Inc - Orlando
- Janus Center for Psychiatric Research - West Palm Beach
- Children's Development Center - Winter Park
California
- Valley Clinical Research - El Centro
- Peninsula Research Assoc, Inc - Rolling Hills Estates
- UCSF-Langely Porter Psych Institute - San Francisco
- Encompass Clinical Research - Spring Valley
- Shire Clinical Research Site - Wildomar
Indiana
- Indiana University School of Medicine - Indianapolis
- Shire Clinical Research Site - Terre Haute
Kansas
- Shire Clinical Research Site - Newton
- Psychiatric Associates - Overland Park
Arizona
- Melmed Center - Scottsdale
Illinois
- Capstone Clinical Research - Libertyville
Kentucky
- Kentucky Pediatric/Adult Research - Bardstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2007-06-28 |
| Est. Completion | 2008-01-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00500071
The ClinicalTrials.gov registry entry for NCT00500071 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (152% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 1 intervention - of which Vyvanse (lisdexamfetamine dimesylate) is the first listed.
NCT00500071 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT00500071 about?
NCT00500071 is a clinical study titled "Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD". Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
What is the current status of trial NCT00500071?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 318 participants. The study started on 2007-06-28. Estimated completion is 2008-01-02.
What conditions does trial NCT00500071 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT00500071?
The interventions under investigation include: Vyvanse (lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00500071?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00500071 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.