Aliskiren Prescription Event Monitoring Study (Aliskiren PEM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6339
• EU PAS number:
  EUPAS6338
• Study ID:
  6339
• Official title and acronym:
  Aliskiren Prescription Event Monitoring Study (Aliskiren PEM)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This postmarketing observational Prescription-Event Monitoring (PEM) study was designed to examine the safety and use of the renin inhibitor, aliskiren (Rasilez®), prescribed in general practice in England, licensed for the treatment of essential hypertension. Patients were identified from dispensed National Health Service (NHS) prescription data for aliskiren between February 2008 and November 2010. A questionnaire was sent to the prescribing GP at least 6 months after the prescription was issued, requesting standard prescribing and patient information, as well as details of any events suffered by the patient during and after stopping treatment with aliskiren.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 08/08/2008

Study start date

Actual: 01/02/2008

Date of final study report

Planned: 25/01/2013

Actual: 25/01/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable