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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00499863 |
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
Condition | Intervention | Phase |
---|---|---|
ADHD |
Drug: methylphenidate transdermal system (DAYTRANA) Drug: Placebo |
Phase III |
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 IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Enrollment: | 290 |
Study Start Date: | July 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dose optimization with MTS
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Drug: methylphenidate transdermal system (DAYTRANA)
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
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2: Placebo Comparator
placebo
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Drug: Placebo
Placebo patch
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Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Robert L Finding, MD | University Hospitals Case Medical Center |
Responsible Party: | Shire ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD485-409 |
Study First Received: | July 10, 2007 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00499863 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Central Nervous System Stimulants Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants |
Pharmacologic Actions Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Dopamine Agents Central Nervous System Agents |