drugset / Trial / NCT00269802

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

NCT00269802

Phase 3 Completed Alza Corporation
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
Primary completion
Completion
1999-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 5 mg Oral
Subject Methylphenidate Small molecule 10 mg Oral
Subject Methylphenidate Small molecule 15 mg Oral
Subject Methylphenidate Small molecule 18 mg Oral
Subject Methylphenidate Small molecule 36 mg Oral
Subject Methylphenidate Small molecule 54 mg Oral