Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 1999-12-01
• Target enrollment: 0
• Participant gender: All

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 disorder (ADHD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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