CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
Abiraterone acetate +1 moredrug
Likely dose
Not stated in 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/NCT01517802
NCT01517802Phase 3Completed

A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study

Janssen Research & Development, LLC·interventional·Posted Jan 25, 2012·Updated May 10, 2022

In Brief

A Phase 3 clinical trial evaluating Abiraterone acetate and Prednisone for Metastatic Castration-resistant Prostate Cancer and Metastatic Breast Cancer. Completed, enrolled 32 participants across 22 sites in 7 countries.

Detailed Summary

The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Germany, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartMar 28, 2012
Primary CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 14.4 years ago

Interventions

Abiraterone acetatedrug

Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily

Prednisonedrug

Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily