Status: Finalised First registered on: 11/04/2014
Last updated on: 14/04/2014
1. Study identification
EU PAS Register NumberEUPAS6338
Official titleAliskiren Prescription Event Monitoring Study
Study title acronymAliskiren PEM
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/08/2008
Start date of data collection01/02/2008
Start date of data analysis
Date of interim report, if expected
Date of final study report25/01/201325/01/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Shakir
First name Saad
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org
Public Enquiries
Title Professor 
Last name Shakir 
First name Saad 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org 
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