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
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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of dexmethylphenidate HCl in modulating dopamine receptors for ADHD treatment?
How does the efficacy of dexmethylphenidate compare to standard stimulant therapies like methylphenidate and amphetamines in pediatric ADHD?
What biomarkers are associated with response prediction to extended-release stimulant medications in ADHD patients aged 6-12?
What adverse events were observed in NCT00301236 and how do they compare to other phase 3 ADHD medications trials sponsored by Novartis?
How does the pharmacokinetic profile of dexmethylphenidate influence its tolerability compared to other CNS stimulant drug classes in children?
Trial Locations
- Locations (1)
Novartis Investigational Site
🇺🇸Houston, Texas, United States
Novartis Investigational Site🇺🇸Houston, Texas, United States