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

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

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 Overview

• Status: Completed
• Conditions: ADHD, ADD
• Intervention / Treatment: Drug: Dexmethylphenidate HCl extended-release capsules

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 Type: Interventional
• Enrollment: 252
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Novartis Investigational site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Novartis Investigational site
  • California
    • Los Angeles, California, United States, 90095
      • Novartis Investigational site
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Novartis Investigational site
  • Florida
    • Maitland, Florida, United States, 32751
      • Novartis Investigational site
    • Orlando, Florida, United States, 32806
      • Novartis Investigational site
  • Georgia
    • Stone Mountain, Georgia, United States, 30083
      • Novartis Investigational site
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Novartis Investigational site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Novartis Investigational site
    • Prairie Village, Kansas, United States, 66206
      • Novartis Investigational site
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Novartis Investigational site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Novartis Investigational site
  • New Jersey
    • Piscataway, New Jersey, United States, 08855
      • Novartis Investigational site
    • Toms River, New Jersey, United States, 08755
      • Novartis Investigational site
  • New York
    • 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
      • Novartis Investigational site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Novartis Investigational site
    • Raleigh, North Carolina, United States, 27609
      • Novartis Investigational site
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Novartis Investigational site
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Novartis Investigational site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19149
      • Novartis Investigational site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Novartis Investigational site
    • Memphis, Tennessee, United States, 38119
      • Novartis Investigational site
  • Texas
    • Houston, Texas, United States, 77007
      • Novartis Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
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

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: March 8, 2006
• First Submitted That Met QC Criteria: March 9, 2006
• First Posted (Estimate): March 10, 2006

Study Record Updates

• Last Update Posted (Estimate): December 21, 2007
• Last Update Submitted That Met QC Criteria: December 17, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Dexmethylphenidate Hydrochloride
• Other Study ID Numbers: CRIT124E2305