Trials / Completed
CompletedNCT02200614
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,509 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Darolutamide (Nubeqa, BAY1841788) | Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg. |
| DRUG | Placebo | Matching placebo 2 tablets twice daily with food. |
Timeline
- Start date
- 2014-09-12
- Primary completion
- 2018-09-03
- Completion
- 2021-06-14
- First posted
- 2014-07-25
- Last updated
- 2022-06-28
- Results posted
- 2019-10-29
Locations
404 sites across 36 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02200614. Inclusion in this directory is not an endorsement.