Study identification

PURI

https://redirect.ema.europa.eu/resource/40844

EU PAS number

EUPAS1777

Study ID

40844

Official title and acronym

Impact of risk minimisation in patients treated with rosiglitazone-containing products

DARWIN EU® study

No

Study countries

Denmark
United Kingdom

Study description

This study will examine the effects of regulatory risk-minimisation measures on utilization of rosiglitazone containing products in the population, on incidence of acute drug reactions and on potential changes in objective diseases parameters in individual patients.

Study status

Finalised
Research institution and networks

Institutions

Boston Collaborative Drug Surveillance Program (GPRD access) Boston, USA

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol
English (200.49 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable