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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00254878 |
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.
Condition | Intervention | Phase |
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ADHD |
Drug: Methylphenidate hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A 7 Week Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Evaluation of the Efficacy and Safety of Two Different Brands of Modified-Release Oral Dosage Forms of Methylphenidate-HCl (20 mg, q.d.) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14 |
Estimated Enrollment: | 130 |
Study Start Date: | October 2005 |
Study Completion Date: | February 2006 |
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.
Ages Eligible for Study: | 6 Years to 14 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study:
Exclusion Criteria:
Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CRIT124DDE01 |
Study First Received: | November 15, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00254878 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ADHD, Methylphenidate hydrochloride, modified-release |
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 |