Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00554229 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 896
- Enrollment target
NCT00554229: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00554229 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 896 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554229, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 896 participants
- Enrollment target
Study Summary
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. * ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases. * All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. * Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. * No patients will be deprived of standard prostate cancer therapy.
Primary Outcome
Median time (in months) from randomisation until death using the Kaplan-Meier method
Interventions
- DRUG Placebo
- DRUG ZD4054
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 896 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00554229 record still lists
NCT00554229 is an interventional study that assigns participants to a tested intervention. The registered 896 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00554229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00554229 about?
NCT00554229 is a clinical study titled "A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases". Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared wi...
What is the current status of trial NCT00554229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 896 participants. The study started on 2007-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00554229?
The interventions under investigation include: Placebo (DRUG), ZD4054 (DRUG).
Who is sponsoring clinical trial NCT00554229?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00554229's enrollment target sits among peer trials
896 361st of 2000 higher than 1,640 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04862663 · 895 participants · Phase 3
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
- NCT02352116 · 900 participants · NA
Evaluation of Post-PACU Pain Management in Pediatric Surgery
- NCT02414347 · 900 participants
F 18 T807 Tau PET Imaging of Alzheimer's Disease
- NCT02670408 · 900 participants
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia