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Sponsored by: |
Shire Pharmaceutical Development |
Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00444574 |
This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).
Condition | Intervention | Phase |
Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate |
Phase III |
MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
Drug Information available for: | Methylphenidate hydrochloride Methylphenidate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Enrollment: | 282 |
Study Start Date: | September 2004 |
Study Completion Date: | June 2005 |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
EXCLUSION CRITERIA:
(FDA Recall Information) 
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(FDA Medical Product Safety Alerts) 
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(FDA-approved label) 
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(Synopsis of study results) 
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Study ID Numbers: | SPD485-302 |
First Received: | March 6, 2007 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00444574 |
Health Authority: | United States: Food and Drug Administration |
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