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

Study identification

• 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 institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

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

Study timelines

Date when funding contract was signed

Actual:14/12/2010

Study start date

Planned:01/02/2011

Actual:01/02/2011

Data analysis start date

Planned:01/02/2011

Actual:01/02/2011

Date of interim report, if expected

Planned:01/04/2011

Actual:01/05/2011

Date of final study report

Planned:01/10/2011

Actual:17/10/2011

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable