Status: Finalised First registered on: 25/10/2013
Last updated on: 18/11/2020
1. Study identification
EU PAS Register NumberEUPAS5035
Official titleMultinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled NVA237 in Europe
Study title acronymNVA237 PASS
Study typeObservational study
Brief description of the studyIn the context of the NVA237 marketing application in Europe, the Committee for Medicinal Products for human use (CHMP) required the conduct of a post-authorization safety study (PASS) to assess the association between the use of NVA237 and cardiovascular and cerebrovascular events. The objectives of this study are to assess the incidence rates and hazard ratio of 1) cardiovascular and cerebrovascular outcomes and 2) mortality among new users of inhaled NVA237 with COPD compared to new users of comparator drugs (long acting antimuscarinic antagonists [LAMAs] excluding NVA237) or long acting β2 agonists (LABAs) with COPD. This study will be a multinational, multi-database cohort study using information from five European electronic health care databases from the Netherlands, Italy, United Kingdom (UK), Denmark and Spain in new users of NVA237 vs. new users of two comparator drug classes.
Was this study requested by a regulator?Yes:
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableCNVA237A2402T
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

Aarhus University Dept. of Clinical Epidemiology
Health Search-SIMG
Erasmus MC Pharmacoepi
SIDIAP Jordi Gol, Spain
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 signed07/05/2013
Start date of data collection01/11/2012
Start date of data analysis25/10/201325/10/2013
Date of interim report, if expected04/12/2013
Date of final study report30/11/201717/11/2017
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)44613241111 
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)44613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registries@novartis.com 
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