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NCT01715285 - A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (m

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)


CSR Summary

Not Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Abiraterone acetate
Product Name
ZYTIGA¬ģ
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
1,209
% Female
0.0%
% White
N/A
Product Class
Hormones
Sponsor Protocol Number
212082PCR3011
Data Partner
Johnson & Johnson
Condition Studied
Neoplasms, Prostatic
Mean/Median Age (Years)
67.1

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

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