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NCT01606228 - An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER among Treatment-Naive and Newly Diagnosed Patients with Schizophrenia

An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER among Treatment-Naive and Newly Diagnosed Patients with Schizophrenia

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CSR Summary

Not Available


Primary Citation

Trial has yet to be published


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Paliperidone
Product Name
INVEGA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
188
% Female
N/A
% White
N/A
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
R076477SCH3033
Data Holder
Johnson & Johnson
Condition Studied
Schizophrenia
Mean/Median Age (Years)
N/A

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Protocol with Amendments
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.