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NCT00638690 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Abiraterone acetate
Product Name
ZYTIGA¬ģ
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
1,195
Product Class
Hormones
Sponsor Protocol Number
COU-AA-301
Data Holder
Johnson & Johnson
Condition Studied
Neoplasms, Prostatic

Supporting Documentation

Analysis Datasets
Annotated Case Report Form (CRF)
Clinical Study Report
Collected Datasets
Data Definition Specification
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.