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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |