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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00301236 |
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Condition | Intervention | Phase |
---|---|---|
ADHD, ADD |
Drug: Dexmethylphenidate HCl extended-release capsules |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder |
Estimated Enrollment: | 252 |
Study Start Date: | February 2006 |
Study Completion Date: | November 2006 |
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CRIT124E2305 |
Study First Received: | March 8, 2006 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00301236 |
Health Authority: | United States: Food and Drug Administration |
ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Coronary Artery Disease |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |