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NCT00326391 - A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA (Methylphenidate HCl) Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder at Doses of 36

A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA (Methylphenidate HCl) Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder at Doses of 36 mg, 54 mg, 72 mg, 90 mg, or 108 mg Per Day


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Annotated CRF

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Product Info

Generic Name
Methylphenidate HCl
Product Name
CONCERTA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
229
% Female
12.0%
% White
86.0%
Product Class
Stimulants/ADHD/Anorexiants
Sponsor Protocol Number
02-159/CR011560
Data Holder
Johnson & Johnson
Condition Studied
Attention Deficit Hyperactivity Disorder
Mean/Median Age (Years)
39.0

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

Disclaimer

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