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Multiple NCT#s - OPTICS Trial Bundle

OPTICS Trial Bundle

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CSR Summary

Multiple CSR Summaries


Primary Citation

Multiple Publications


Data Specification

Not Yet Available


Annotated CRF

Not Yet Available

Product Info

Generic Name
Paliperidone
Product Name
INVEGA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
6,828
Product Class
Atypical antipsychotics
Sponsor Protocol Number
Multiple
Data Holder
Johnson & Johnson
Condition Studied
Schizophrenia

Supporting Documentation

Analysis Datasets
Clinical Study Report
Protocol with Amendments
Statistical Analysis Plan
Additional Information: 

OPTICS Trial Bundle
The OPTICS trial bundle includes socio-demographic and phenotypic (i.e., clinical) information for the subset of participants who had both phenotypic and genetic information. Phenotypic information for the remainder of the study participants will be included once it has been de-identified.  Due to privacy concerns, genetic information cannot be released.

Documentation
Descriptive variable labels are provided in all of the data files.

Redacted CSRs, protocols, and statistical analysis plans are available for the following trials:
R092670-PSY-3007, R092670-PSY-3004, R092670-PSY-3001, R076477-SCH-303, R076477-SCH-3015, R076477-SCA-3002, R076477-SCA-3001, and R076477-BIM-3003

Documentation will be updated as it becomes available.

A detailed list of the documentation available for each trial can be found here.

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.