Status: Finalised First registered on: 26/09/2013
Last updated on: 23/11/2020
1. Study identification
EU PAS Register NumberEUPAS4845
Official titleMultinational, multi-database drug utilization study of inhaled NVA237 in Europe
Study title acronymNVA237 DUS
Study typeObservational study
Brief description of the studyIn the context of the NVA237 marketing authorization application (and it’s multiple marketing authorization applications), the Committee for Medicinal Products for human use (CHMP) recommended conditions for marketing authorization and product information and suggested to conduct a post-authorization drug utilization study. The objectives of this study are to estimate the subpopulation with cardiovascular co-morbidity and to identify patients groups with missing information in the Risk Management Plan.
Was this study requested by a regulator?Don't know
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableCNVA237A2401T
2. Research centres and Investigator details
Coordinating study entity
Centre nameNovartis Pharmaceuticals
Centre locationEast Hanover, NJ
Details of (Primary) lead investigator
Title Ms
Last name Novartis
First name Clinical Disclosure Officer
Is this study being carried out with the collaboration of a research network?
Yes
EU-ADR Alliance
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Health Search-SIMG
Erasmus MC Pharmacoepi
SIDIAP Jordi Gol, Spain
Department of Clinical Epidemiology, Denmark
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/03/201305/07/2013
Start date of data collection01/11/201201/11/2012
Start date of data analysis27/09/2013
Date of interim report, if expected06/12/2013
Date of final study report30/11/201528/04/2016
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 Ms
Last name Novartis
First name Clinical Disclosure Officer
Address line 1Novartis Pharma AG
Address line 2 
Address line 3 
CityBasel 
PostcodeCH-4002 
CountrySwitzerland
Phone number (incl. country code)41613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registries@novartis.com
Public Enquiries
Title Ms 
Last name Novartis 
First name Clinical Disclosure Officer 
Address line 1Novartis Pharma AG 
Address line 2 
Address line 3 
CityBasel 
PostcodeCH-4002 
CountrySwitzerland 
Phone number (incl. country code)41613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registries@novartis.com 
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