Study identification

PURI

https://redirect.ema.europa.eu/resource/38133

EU PAS number

EUPAS5035

Study ID

38133

Official title and acronym

Multinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled NVA237 in Europe (NVA237 PASS)

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

In 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.

Study status

Finalised
Research institutions and networks

Institutions

SIDIAP Jordi Gol Spain

Networks

Contact details

Clinical Disclosure Officer Novartis

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis
Study protocol
Initial protocol

NVA237A2402T-v03--protocol_Redacted

English (2.76 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)