Cilostazol Drug Utilisation Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24988
• 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 institution and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute (IACS)

Spain

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Study timelines

Date when funding contract was signed

Actual: 15/01/2013

Study start date

Actual: 08/03/2013

Data analysis start date

Actual: 09/04/2013

Date of interim report, if expected

Actual: 31/03/2015

Date of final study report

Planned: 18/05/2017

Actual: 01/02/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Otsuka Pharmaceutical Europe, Ltd.

Study protocol

Initial protocol

Cilostazol Protocol 2013Feb28

Updated protocol

Cilostazol DUS2 Operational Protocol V02_05Nov2015

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)