Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
Status and phase
Completed
Phase 3
Conditions
ADHD, ADD
Treatments
Drug: Dexmethylphenidate HCl extended-release capsules
Details and patient eligibility
About
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.
Full 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.
Sex
All
Ages
6 to 12 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
25
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Data sourced from clinicaltrials.gov
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