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NCT02200614 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,509
- Enrollment target
NCT02200614: Completed Phase 3 study, sponsored by Bayer.
NCT02200614 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,509 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02200614, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,509 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Primary Outcome
Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
Interventions
- DRUG Placebo
- DRUG Darolutamide (Nubeqa, BAY1841788)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,509 participants |
| Start Date | 2014-09-12 |
| Est. Completion | 2021-06-14 |
| Phase | Phase 3 |
What the finished NCT02200614 record still lists
NCT02200614 is an interventional study that assigns participants to a tested intervention. Its 1,509 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02200614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02200614 about?
NCT02200614 is a clinical study titled "Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer". The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
What is the current status of trial NCT02200614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,509 participants. The study started on 2014-09-12. Estimated completion is 2021-06-14.
What interventions are being tested in trial NCT02200614?
The interventions under investigation include: Placebo (DRUG), Darolutamide (Nubeqa, BAY1841788) (DRUG).
Who is sponsoring clinical trial NCT02200614?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02200614's enrollment target sits among peer trials
1,509 157th of 2000 higher than 1,844 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
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