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NCT00083668 - A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension,

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Paliperidone
Product Name
INVEGA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
407
% Female
32.0%
% White
49.0%
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
R076477-SCH-305
Data Partner
Johnson & Johnson
Condition Studied
Schizophrenia
Mean/Median Age (Years)
36.8

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
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.