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NCT00246220 - A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension,

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Methylphenidate HCl
Product Name
CONCERTA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
402
% Female
45.6%
% White
97.5%
Product Class
Stimulants/ADHD/Anorexiants
Sponsor Protocol Number
42603ATT3002
Data Holder
Johnson & Johnson
Condition Studied
Attention Deficit Hyperactivity Disorder
Mean/Median Age (Years)
34.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3
Additional Information: 

CSR Summary for German extension study available here

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.