WHO ICTRP trial

Radium-223 Dichloride in the treatment of patients diagnosed with prostate…

EUCTR2012-000075-16-SE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2012-000075-16-SE
Public title Radium-223 Dichloride in the treatment of patients diagnosed with prostate cancer that has spread to the bone
Scientific title Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis - Radium-223 dichloride in the treatment of CRPC/HRPC patients with bone metastasis
Primary sponsor Bayer HealthCare AG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Finland;Spain;Ireland;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
Conditions Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis MedDRA version: 18.1 Level: LLT Classification code 10036916 Term: Prostate cancer stage D System Organ Class: 100000004864 ;Therapeutic…
Interventions Product Name: Radium-223 dichloride Product Code: BAY88-8223 Pharmaceutical Form: Solution for injection INN or Proposed INN: Radium-223 dichloride CAS Number: 444811-40-9 Current Sponsor code: BAY88-8223 Concentration unit: kBq/ml…
Registration date Mar 28, 2012
Target size 1500
Secondary IDs BAY88-8223/16216
Registry page clinicaltrialsregister.eu

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