Status:
COMPLETED
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
Lead Sponsor:
Novartis
Conditions:
ADHD, ADD
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Detailed Description
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Eligibility Criteria
Inclusion
- Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term
Exclusion
- Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00301236
Start Date
February 1 2006
End Date
November 1 2006
Last Update
December 21 2007
Active Locations (25)
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1
Novartis Investigational Site
Mesa, Arizona, United States, 85210
2
Novartis Investigational Site
Little Rock, Arkansas, United States, 72205
3
Novartis Investigational Site
Los Angeles, California, United States, 90095
4
Novartis Investigational Site
Boulder, Colorado, United States, 80304