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Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

NCT01591122 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2020-01-21

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Conditions

Interventions

DRUG

Placebo and prednisone

Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.

DRUG

Abiraterone acetate and prednisone

Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, 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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-27
Primary Completion
2016-12-31
Completion
2019-01-31

Countries

  • China
  • Malaysia
  • Russia
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT01591122 on ClinicalTrials.gov