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

NCT ID: NCT00301236

Last Updated: 2007-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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ADHD, ADD

Keywords

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ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dexmethylphenidate HCl extended-release capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigational Site

Mesa, Arizona, United States

Site Status

Novartis Investigational Site

Little Rock, Arkansas, United States

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Novartis Investigational Site

Los Angeles, California, United States

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Novartis Investigational Site

Boulder, Colorado, United States

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Novartis Investigational Site

Maitland, Florida, United States

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Novartis Investigational Site

Orlando, Florida, United States

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Novartis Investigational Site

Stone Mountain, Georgia, United States

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Novartis Investigational Site

Libertyville, Illinois, United States

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Novartis Investigational Site

Overland Park, Kansas, United States

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Prairie Village, Kansas, United States

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Cambridge, Massachusetts, United States

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Novartis Investigational Site

Las Vegas, Nevada, United States

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Novartis Investigational Site

Piscataway, New Jersey, United States

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Novartis Investigational Site

Toms River, New Jersey, United States

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New York, New York, United States

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Novartis Investigational Site

New York, New York, United States

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Novartis Investigational Site

Staten Island, New York, United States

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Novartis Investigational Site

Chapel Hill, North Carolina, United States

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Novartis Investigational Site

Raleigh, North Carolina, United States

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Columbus, Ohio, United States

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Gresham, Oregon, United States

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Novartis Investigational Site

Philadelphia, Pennsylvania, United States

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Novartis Investigational Site

Jackson, Tennessee, United States

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Novartis Investigational Site

Memphis, Tennessee, United States

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Novartis Investigational Site

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CRIT124E2305

Identifier Type: -

Identifier Source: org_study_id