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| Sponsor: | Shire Pharmaceutical Development |
|---|---|
| Information provided by: | Shire Pharmaceutical Development |
| ClinicalTrials.gov Identifier: | NCT00500149 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Vyvanse (lisdexamfetamine dimesylate) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 129 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Vyvanse (lisdexamfetamine dimesylate)
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).
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Univ. of CA, Irvine Child Development Center | |
| Irvine, California, United States | |
| Shire Clinical Research Site | |
| Wildomar, California, United States | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States | |
| United States, Nevada | |
| Center for Psychiatry & Behavioral Medicine Inc | |
| Las Vegas, Nevada, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| Duke Child & Family Study Center | |
| Durham, North Carolina, United States | |
| United States, Texas | |
| Shire Clinical Research Site | |
| Houston, Texas, United States | |
| Shire Clinical Research Site | |
| Lubbock, Texas, United States | |
| Principal Investigator: | Sharon B Wigal, PhD | UCI Irvine |
More Information
| Responsible Party: | Timothy Whitaker, M.D., Shire Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00500149 History of Changes |
| Other Study ID Numbers: | SPD489-311 |
| Study First Received: | July 10, 2007 |
| Results First Received: | December 2, 2008 |
| Last Updated: | February 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dextroamphetamine |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |