CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
Abiraterone acetate +2 moredrug
Likely dose
Abiraterone acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01695135
NCT01695135Phase 3Completed

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Janssen Research & Development, LLC·interventional·Posted Sep 27, 2012·Updated Jul 18, 2019

In Brief

A Phase 3 clinical trial evaluating Abiraterone acetate, Placebo, and 1 other intervention for Prostate Neoplasms. Completed, enrolled 214 participants across 11 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2012
Enrollment StartAug 9, 2012
Primary CompletionJun 20, 2014
Study CompletionMay 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.8 years ago

Interventions

Abiraterone acetatedrug

Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily

Placebodrug

Placebo (4 tablets) taken orally once daily

Prednisonedrug

Prednisone 5 mg tablet taken orally twice daily