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Attention Deficit Hyperactivity Disorder

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

Sponsored by Alza Corporation, DE, USA

About this trial

Last updated 14 years ago

Study ID

CR005995

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
6 to 12 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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