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Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

NCT04464226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-04-15

No results posted yet for this study

Summary

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Conditions

Interventions

DRUG

Darolutamide (Nubeqa, BAY1841788)

Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2028-06-26
Completion
2028-06-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464226 on ClinicalTrials.gov