A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 1999-02-01
• Target enrollment: 0
• Participant gender: All

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 treatment of Attention Deficit Hyperactivity Disorder in children. Both OROS® Methylphenidate HCl and Ritalin® contain the central nervous system stimulant, methylphenidate HCl.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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