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NCT00111189 - A Randomized Double-blind Placebo-controlled Parallel Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia. Placebo Consists of 20% Intralipid (200 mg/mL) Injectable Emulsion

A Randomized Double-blind Placebo-controlled Parallel Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia. Placebo Consists of 20% Intralipid (200 mg/mL) Injectable Emulsion


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Paliperidone palmitate
Product Name
INVEGA SUSTENNA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
414
% Female
45.0%
% White
66.0%
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
R092670PSY3001
Data Partner
Johnson & Johnson
Condition Studied
Schizophrenia
Mean/Median Age (Years)
39.0

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.