Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
Phase 3
Completed
- Conditions
- ADHD, ADD
- Registration Number
- NCT00301236
- Lead Sponsor
- Novartis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
Inclusion Criteria
- Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigational Site
🇺🇸Houston, Texas, United States