A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in non-metastatic Hormone Resistant Prostate Cancer - ENTHUSE M0

Study identifier:D4320C00015

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

Medical condition

prostate cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

ZD4054, Palcebo

Sex

Male

Actual Enrollment

2577

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jan 2008
Primary Completion Date: 01 Jan 2011
Study Completion Date: 01 May 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria