Study identification

PURI

https://redirect.ema.europa.eu/resource/38226

EU PAS number

EUPAS4845

Study ID

38226

Official title and acronym

Multinational, multi-database drug utilization study of inhaled NVA237 in Europe (NVA237 DUS)

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

In 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.

Study status

Finalised
Research institutions and networks

Institutions

SIDIAP Jordi Gol Spain, Department of Clinical Epidemiology Denmark

Networks

Contact details

Clinical Disclosure Officer Novartis

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

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

NVA237A2401T-v02--protocol_Redacted

English (847.73 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Unknown

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

EU RMP category 3 (required)