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NCT01323192 - A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day

A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day


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
284
% Female
51.0%
% White
100.0%
Product Class
Stimulants/ADHD/Anorexiants
Sponsor Protocol Number
JNS001-JPN-A01
Data Holder
Johnson & Johnson
Condition Studied
Attention Deficit Hyperactivity Disorder
Mean/Median Age (Years)
33.5

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Statistical Analysis Plan
Study Phase 
3

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.