Skip to main content

NCT00866996 - A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder

A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Methylphenidate HCl
Product Name
CONCERTA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
1,323
% Female
25.7%
% White
76.7%
Product Class
Stimulants/ADHD/Anorexiants
Sponsor Protocol Number
CR008329 (12-101)
Data Partner
Johnson & Johnson
Condition Studied
Attention Deficit Hyperactivity Disorder
Mean/Median Age (Years)
8.9

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Study Phase 
4

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.