Status:
COMPLETED
Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of OROS® Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit hyperactivity diso...
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 one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
- whose primary care physician agrees that it is appropriate to participate in this study
- who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
- who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
- who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator
Exclusion
- Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
- having a known hypersensitivity to methylphenidate
- having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
- if female, have begun menstruation
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 1999
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00269815
End Date
December 1 1999
Last Update
June 14 2011
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