Study identification

EU PAS number

EUPAS21731

Study ID

46710

Official title and acronym

Prospective, multi-country, observational registry to collect clinical

DARWIN EU® study

No

Study countries

Austria
Croatia
Czechia
France
Germany
Italy
Netherlands
Portugal
Spain
Sweden

Study description

To collect clinical information in patients with Cushing’s syndrome (CS) exposed to ketoconazole, to assess drug utilization patterns and to document the safety, and effectiveness of ketoconazole. The primary objective is to collect and assess safety data with a particular focus on the important identified risks of hepatotoxicity and QT prolongation. The secondary objectives are to collect and assess other safety data, to evaluate the effectiveness and drug utilization patterns of ketoconazole.

Study status

Ongoing
Research institutions and networks

Institutions

Hôpital de la Conception Marseille Centre Hospitalier Universitaire de Bordeaux, Hôpital Bicêtre Paris University Hospital Zagreb, Hôpital Universitaire de Grenoble Dr Sahlgrenska University Hospital Goteborg, Hôpital Cochin Paris Centro Hospitalar de Lisboa Ocidental, Institut de Recerca de la Santa Creu i Sant Pau Barcelona Hospitalar Universitário de Coimbra, Hospital clinic Barcelona Centro Hospitalar Universitário do Porto, Hospital Universitario de La Ribera University Hospital in Prague, Hospital General Universitario Gregorio MaranonMadrid Charité Universitatsmedizin Berlin, Hospital Universitario de Albacete Klinikum der Universitat München, Erasmus University Medical Center Rotterdam MEDICOVER Oldenburg MVZ- Oldenburg

Networks

ERCUSYN

Contact details

Myriam Bou Nader

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

HRA Pharma Rare Diseases
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/003906/ANX/002,EMEA/H/C/PSP/0040