Status:
COMPLETED
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
Lead Sponsor:
UCB Pharma
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side eff...
Eligibility Criteria
Inclusion
- 6 -12 years of age, inclusive
- Have a diagnosis of ADHD
- Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.
Exclusion
- IQ below 80.
- The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
- History of seizures (excluding uncomplicated childhood febrile seizures).
- Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
- Comorbid psychiatric diagnosis.
- Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00381758
Start Date
May 1 2002
End Date
August 1 2002
Last Update
March 10 2008
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