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Completed Phase 3 Interventional Results available

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

ClinicalTrials.gov ID: NCT01193244

Public ClinicalTrials.gov record NCT01193244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Study identification

NCT ID
NCT01193244
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,560 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1, 2010 (Actual)
Primary completion
Jan 1, 2014 (Actual)
Completion
Apr 7, 2016 (Actual)
Last update posted
May 17, 2017

2010 – 2016

United States locations

U.S. sites
48
U.S. states
27
U.S. cities
48
Facility City State ZIP Site status
Not listed Anchorage Alaska — —
Not listed Tucson Arizona — —
Not listed Duarte California — —
Not listed Highland California — —
Not listed Orange California — —
Not listed Sacramento California — —
Not listed San Francisco California — —
Not listed Aurora Colorado — —
Not listed Denver Colorado — —
Not listed Deerfield Beach Florida — —
Not listed Fort Myers Florida — —
Not listed Jacksonville Florida — —
Not listed Orlando Florida — —
Not listed Port Saint Lucie Florida — —
Not listed Jeffersonville Indiana — —
Not listed Kansas City Kansas — —
Not listed New Orleans Louisiana — —
Not listed Baltimore Maryland — —
Not listed Boston Massachusetts — —
Not listed Lansing Michigan — —
Not listed Duluth Minnesota — —
Not listed Corinth Mississippi — —
Not listed Columbia Missouri — —
Not listed Jefferson City Missouri — —
Not listed Omaha Nebraska — —
Not listed Las Vegas Nevada — —
Not listed Hackensack New Jersey — —
Not listed East Syracuse New York — —
Not listed New York New York — —
Not listed Durham North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Kettering Ohio — —
Not listed Tualatin Oregon — —
Not listed Hershey Pennsylvania — —
Not listed Lancaster Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed Piitsburgh Pennsylvania — —
Not listed Charleston South Carolina — —
Not listed Columbia South Carolina — —
Not listed Chattanooga Tennessee — —
Not listed Nashville Tennessee — —
Not listed Amarillo Texas — —
Not listed Bedford Texas — —
Not listed Dallas Texas — —
Not listed Denton Texas — —
Not listed Tyler Texas — —
Not listed Salt Lake City Utah — —
Not listed Norfolk Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 192 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01193244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 17, 2017 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01193244 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →