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Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00301236
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : December 21, 2007
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
ADHD, ADD Drug: Dexmethylphenidate HCl extended-release capsules Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.

Secondary Outcome Measures :
  1. Assessment of the symptoms by the patient's parent after five weeks of treatment.
  2. Change in severity of the illness assessed by the physician after 5 weeks of treatment
  3. Improvement of the illness assessed by the physician after 5 weeks of treatment
  4. Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term

Exclusion Criteria:

  • Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301236


Locations
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United States, Arizona
Novartis Investigational Site
Mesa, Arizona, United States, 85210
United States, Arkansas
Novartis Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Novartis Investigational Site
Los Angeles, California, United States, 90095
United States, Colorado
Novartis Investigational Site
Boulder, Colorado, United States, 80304
United States, Florida
Novartis Investigational Site
Maitland, Florida, United States, 32751
Novartis Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Novartis Investigational Site
Stone Mountain, Georgia, United States, 30083
United States, Illinois
Novartis Investigational Site
Libertyville, Illinois, United States, 60048
United States, Kansas
Novartis Investigational Site
Overland Park, Kansas, United States, 66211
Novartis Investigational Site
Prairie Village, Kansas, United States, 66206
United States, Massachusetts
Novartis Investigational Site
Cambridge, Massachusetts, United States, 02138
United States, Nevada
Novartis Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Novartis Investigational Site
Piscataway, New Jersey, United States, 08855
Novartis Investigational Site
Toms River, New Jersey, United States, 08755
United States, New York
Novartis Investigational Site
New York, New York, United States, 10029
Novartis Investigational Site
New York, New York, United States, 10032
Novartis Investigational Site
Staten Island, New York, United States, 10305
United States, North Carolina
Novartis Investigational Site
Chapel Hill, North Carolina, United States, 27514
Novartis Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Novartis Investigational Site
Columbus, Ohio, United States, 43205
United States, Oregon
Novartis Investigational Site
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Novartis Investigational Site
Philadelphia, Pennsylvania, United States, 19149
United States, Tennessee
Novartis Investigational Site
Jackson, Tennessee, United States, 38305
Novartis Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novartis Investigational Site
Houston, Texas, United States, 77007
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00301236    
Other Study ID Numbers: CRIT124E2305
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
Keywords provided by Novartis:
ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dexmethylphenidate Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
 Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents