A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer with Bone Metastases - ENTHUSE M1
Study identifier:D4320C00014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2007-003227-20
CTIS identifier:N/A
Study Complete
Official Title
A Phase III Trial to test the efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, versus Placebo in Patients with Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who are Pain Free and Mildly Symptomatic.
Medical condition
prostate cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
ZD4054, Placebo
Sex
Male
Actual Enrollment
896
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Nov 2007
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Aug 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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZD4054 ZD4054 10 mg oral tablet once daily | Drug: ZD4054 ZD4054 10 mg oral tablet once daily Other Name: Zibotentan |
| Placebo Comparator: Placebo Matching Placebo, oral tablets once daily | Drug: Placebo Matching placebo oral tablet once daily |
Contacts
Investigators
Principal Investigator
Martin Gleave
The Prostate Centre at Vancouver General Hospital
