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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141050
First Posted: September 1, 2005
Last Update Posted: December 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
August 30, 2005
September 1, 2005
December 21, 2007
May 2005
Not Provided
Change in attention and deportment measured at 2 hours post-dose
Reduction of symptoms in attention and deportment
Complete list of historical versions of study NCT00141050 on ClinicalTrials.gov Archive Site
  • 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.
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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
ADHD
Drug: Focalin XR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
July 2005
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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
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00141050
CRIT124EUS12
Not Provided
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Novartis
Not Provided
Principal Investigator: Matthew Brams, MD Bayou City Research
Novartis
December 2007

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