Study identification

PURI

https://redirect.ema.europa.eu/resource/16740

EU PAS number

EUPAS2765

Study ID

16740

Official title and acronym

Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products

DARWIN EU® study

No

Study countries

Denmark
Netherlands
United States

Study description

The study has the following objectives 1: To provide observational data on drug utilisation patterns of pioglitazone-containing products in the European Union (EU) and to study associations between changes in drug utilisation patterns and the regulatory decisions in the form of DHPC. 2a: To analyse events in patients discontinuing pioglitazone after the DHPC, including adverse drug events, alterations in glycaemic control, and modification of other objective parameters of disease.2b: To analyse contraindications and events in patients continuing or starting pioglitazone, including adverse drug events, alterations in glycaemic control, and modification of other objective parameters of disease.3. To evaluate effectiveness of risk minimisation measures recommended by CHMP based on results obtained for Objective 1 and Objective 2.4. To provide practical recommendations for improving effectiveness of risk minimisation measures.The objectives of the study will be achieved using data from automated pharmacoepidemiologic databases in three EU Member states: Denmark, The Netherlands, and United Kingdom.

Study status

Finalised
Research institution and networks

Institutions

Boston Collaborative Drug Surveillance Program Boston, USA

Networks

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
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

D4 b Final Study Protocol vFinal

English (414.76 KB - PDF)View document
Updated protocol

D4 b Final Study Protocol vFinal_Amendment 07 11 2012

English (385.66 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