Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00141063

First received: August 30, 2005

Last updated: December 17, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

December 17, 2007

Start Date ^ICMJE

June 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in attention and deportment measured at 2 hours post-dose

Original Primary Outcome Measures ^ICMJE

Reduction of symptoms in attention and deportment

Change History

Complete list of historical versions of study NCT00141063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Official Title ^ICMJE

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

ADHD

Intervention ^ICMJE

Drug: Focalin XR

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Inability of understand or follow instructions
Is pregnant
Diagnosis of tic disorder
History of seizure disorder

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00141063

Other Study ID Numbers ^ICMJE

CRIT124EUS13

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ann Childress, MD

Center for Psychiatry and Behavioral Medicine

Information Provided By

Novartis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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