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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: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
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 124-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
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 |
What the finished NCT00500071 record still lists
NCT00500071 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 124-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (156% higher).
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 names 20 study sites across 7 states, led by 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
Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00500071's enrollment target sits among peer trials
318 2nd of 18 the highest of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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