Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT00301236|
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : December 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|ADHD, ADD||Drug: Dexmethylphenidate HCl extended-release capsules||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder|
|Study Start Date :||February 2006|
|Study Completion Date :||November 2006|
- Assessment of the symptoms by the patient`s teacher after 5 weeks of treatment.
- Assessment of the symptoms by the patient`s parent after five weeks of treatment.
- Change in severity of the illness assessed by the physician after 5 weeks of treatment
- Improvement of the illness assessed by the physician after 5 weeks of treatment
- Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301236
Show 25 Study Locations
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|