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NCT00650793 - A Randomized, DB, PC and AC, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (6, 9, 12 mg/Day) and Olanzapine (10 mg/Day), With Open-Label Extension, in the T

A Randomized, DB, PC and AC, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (6, 9, 12 mg/Day) and Olanzapine (10 mg/Day), With Open-Label Extension, in the Treatment of Subjects With Schizophrenia - Open Label Phase

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Paliperidone
Product Name
INVEGA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
473
% Female
51.0%
% White
67.0%
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
R076477-SCH-703
Data Holder
Johnson & Johnson
Condition Studied
Schizophrenia
Mean/Median Age (Years)
36.9

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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