A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

NCT01517802 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-05-10

Study results available
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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.

Conditions

Interventions

DRUG

Abiraterone acetate

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

DRUG

Prednisone

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-28
Primary Completion
2021-04-22
Completion
2021-04-22

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517802 on ClinicalTrials.gov