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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00141063 |
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
Condition | Intervention | Phase |
---|---|---|
ADHD |
Drug: Focalin XR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD |
Estimated Enrollment: | 90 |
Study Start Date: | June 2005 |
Study Completion Date: | August 2005 |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nevada | |
Center for Psychiatry & Behavioral Medicine | |
Las Vegas, Nevada, United States, 89128 |
Principal Investigator: | Ann Childress, MD | Center for Psychiatry and Behavioral Medicine |
Study ID Numbers: | CRIT124EUS13 |
Study First Received: | August 30, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00141063 |
Health Authority: | United States: Food and Drug Administration |
ADHD, children |
Dopamine Methylphenidate |
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 |