Detail of the clinical trial
| Title of the trial | An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies |
|---|---|
| EudraCT number | 2019-003618-15 |
| Protocol number | 20321 |
| Sponsor | Bayer Consumer Care AG, Peter-Merian-Strasse 84, 4052 Basel, Switzerland |
| Indications | Oncology |
| Diagnosis | prostate cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Patients |
| Year of receiving the request to Institute (SÚKL) | 2020 |
| Date of approval by Institute (SÚKL) | 25.6.2020 |
| Date of approval by EC | 13.5.2020 |
| Date of initiation CT in ČR | 21.10.2020 |
| Date of ending CT in ČR | |
| Notice | |
| Sites |
Radioterapeutická a onkologická klinika FN Královské Vinohrady , Šrobárova 1150/50, 100 34 Praha 10 Klinika komplexní onkologické péče, Masarykův onkologický ústav, Žlutý kopec 7, 665 52 Brno Urocentrum Praha s.r.o., Karlovo náměstí 319/3,Praha 2,120 00 Nemocnice Jablonec nad Nisou, p.o.,Urologické oddělení,Nemocniční 15,Jablonec nad Nisou,466 60 Všeobecná Fakultní Nemocnice v Praze,Urologická klinika,Ke Karlovu 6,Praha 2,128 08 Androgeos spol., s.r.o., Na Valech 4/289,Praha 6,160 00 |
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