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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2011-06-10
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.
Conditions
- Attention Deficit Hyperactivity Disorder
Interventions
- DRUG
-
OROS methylphenidate HCl
- DRUG
-
Ritalin
- DRUG
Sponsors & Collaborators
-
Alza Corporation, DE, USA
lead INDUSTRY
Principal Investigators
-
Alza Corporation Clinical Trial · ALZA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 1999-02-28
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