Study identification

EU PAS number

EUPAS3596

Study ID

24988

Official title and acronym

Cilostazol Drug Utilisation Study

DARWIN EU® study

No

Study countries

Germany
Spain
Sweden
United Kingdom

Study description

Drug utilisation study (DUS) on the use of cilostazol in several European populations The DUS is a cohort study of new users of cilostazol. Five European population-based automated health databases are participating: Spain (IACS and SIDIAP), Germany (GePaRD--pending approvals), the United Kingdom (THIN), and Sweden (Swedish National Databases). The DUS is being conducted in two phases: DUS1 and DUS2. DUS1 has been completed and evaluated cilostazol as used in clinical practice in the target countries during the period from cilostazol launch through 2011. DUS2 will now be conducted after the implementation of changes to the summary of product characteristics (SmPC) and the follow-up communication activities with health care professionals (HCPs) and will evaluate the impact of these measures during the year 2014.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner

Contact details

Jordi Castellsague

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

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

More details on funding

Otsuka Pharmaceutical Europe, Ltd.
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)