Status:
COMPLETED
A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of OROS® Methylphenidate HCl as compared with placebo and standard immediate-release Ritalin® (taken three time per day) for the trea...
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral disorder in children, affecting 3% to 5% of the school-age population. Behavioral pediatricians, child psychi...
Eligibility Criteria
Inclusion
- Patients who have successfully completed the ALZA screening protocol C-98-011 within the past six months
- taking or have taken in the past 5 - 20 mg of immediate-release methylphenidate (Ritalin®) at least twice a day, 20 - 60 mg of sustained-release methylphenidate (Ritalin-SR®) per day, or a combination of immediate-release and sustained-release methylphenidate up to a daily dose not exceeding 60 mg, or have successfully completed ALZA Protocol C-98-007
- agreeing to take only the supplied study drug as treatment for ADHD during the four-week treatment phase of the study
- who are able to comply with the study visit schedule and whose parent(s) and teacher are willing and able to complete the protocol-specified assessments
- having normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined to be not clinically significant by the investigator
Exclusion
- Patients who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- having glaucoma, an ongoing seizure disorder, a psychotic disorder, clinical depression (and are suicidal or require immediate treatment for depression), or a diagnosis of Tourette's syndrome
- having a known allergy to methylphenidate or currently having significant adverse experiences from methylphenidate
- having a mean of two blood pressure measurements (systolic or diastolic) equal to or greater than the 95th percentile for age, sex, and height at screening
- if female, have begun menstruation
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1999
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00269802
End Date
February 1 1999
Last Update
June 10 2011
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