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Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00141050
First received: August 30, 2005
Last updated: December 17, 2007
Last verified: December 2007

August 30, 2005
December 17, 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.
Not Provided
Not Provided
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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
Not Provided

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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141050
CRIT124EUS12
Not Provided
Not Provided
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