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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

NCT ID: NCT00141050

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

Detailed Description

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Conditions

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ADHD

Keywords

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ADHD, children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Focalin XR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV diagnosis of ADHD
* Males and females aged 6-12

Exclusion Criteria

* Inability to understand or follow instructions
* Is pregnant
* Diagnosis of tic disorder
* History of seizure disorder
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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Matthew Brams, MD

Role: PRINCIPAL_INVESTIGATOR

Bayou City Research

Locations

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Bayou City Research

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CRIT124EUS12

Identifier Type: -

Identifier Source: org_study_id