drugset / Trial / NCT00304681

An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children

NCT00304681

Phase 3 Completed 147 enrolled Janssen-Ortho Inc., Canada
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effectiveness and safety of OROS\*methylphenidate/CONCERTA\* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.

Timeline

Start
Primary completion
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 18 mg Oral
Subject Methylphenidate Small molecule 27 mg Oral
Subject Methylphenidate Small molecule 36 mg Oral
Subject Methylphenidate Small molecule 54 mg Oral