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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,509 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Darolutamide (Nubeqa, BAY1841788)

Trial Details

FieldValue
Enrollment Target 1,509 participants
Start Date 2014-09-12
Est. Completion 2021-06-14
Phase Phase 3

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT02200614

The ClinicalTrials.gov registry entry for NCT02200614 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,509 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02200614 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.