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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00458445 |
The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
Condition | Intervention | Phase |
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Attention Deficit Hyperactivity Disorder |
Drug: SPD465 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 46 |
Study Start Date: | April 2007 |
Ages Eligible for Study: | 19 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Responsible Party: | Shire Pharmaceutical ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD465-311 |
Study First Received: | April 2, 2007 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00458445 |
Health Authority: | United States: Food and Drug Administration |
Attention-Deficit Hyperactivity Disorder (ADHD) |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Pathologic Processes Disease Nervous System Diseases |