Study identification

PURI

https://redirect.ema.europa.eu/resource/19338

EU PAS number

EUPAS3626

Study ID

19338

Official title and acronym

Pan European Multi-Database Bladder Cancer Risk Characterisation Study

DARWIN EU® study

No

Study countries

Finland
Netherlands
Sweden
United Kingdom

Study description

This observational study is being undertaken to further assess the association between pioglitazone use and bladder cancer risk among patients with type 2 diabetes mellitus in four European countries: Finland, Netherlands, Sweden, and United Kingdom.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Pasi Korhonen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda Global Research & Development Centre (Europe) Ltd
Study protocol
Initial protocol

Appendices 1-5

English (1008.28 KB - PDF)View document
Updated protocol

ER12-9433-Actos Pan-European bladder cancer protocol Version 2.0 20Jun2013_NEW CLEANwith signatures

English (796.82 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)