ADHD, ADD
Conditions
Keywords
ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
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.
Interventions
DRUGDexmethylphenidate HCl extended-release capsules
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the symptoms by the patient's teacher after 5 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed