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

Primary Purpose

ADHD, ADD

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexmethylphenidate HCl extended-release capsules
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD, ADD focused on measuring ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release

Eligibility Criteria

6 Years - 12 Years (Child)All Sexes

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

Sites / Locations

  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2006
Last Updated
December 17, 2007
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00301236
Brief Title
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, ADD
Keywords
ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
252 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dexmethylphenidate HCl extended-release capsules
Primary Outcome Measure Information:
Title
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Secondary Outcome Measure Information:
Title
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Title
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Title
Improvement of the illness assessed by the physician after 5 weeks of treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Novartis Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Novartis Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Novartis Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Novartis Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novartis Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Novartis Investigational Site
City
Stone Mountain
State/Province
Georgia
ZIP/Postal Code
30083
Country
United States
Facility Name
Novartis Investigational Site
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Novartis Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Novartis Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Novartis Investigational Site
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
Novartis Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Novartis Investigational Site
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855
Country
United States
Facility Name
Novartis Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Novartis Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novartis Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novartis Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Novartis Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Novartis Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Novartis Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Novartis Investigational Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Novartis Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Novartis Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Novartis Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Novartis Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States

12. IPD Sharing Statement

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

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