Study identification

PURI

https://redirect.ema.europa.eu/resource/37308

EU PAS number

EUPAS7674

Study ID

37308

Official title and acronym

Multinational database cohort study to assess RMP specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

Multinational database cohort study to assess RMP-specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe

Study status

Finalised
Research institution 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:

Data collection

Actual:

Start date of data analysis

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 Pharma AG
Study protocol
Initial protocol

QVA149A2402-v02--protocol_redacted

English (1.67 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)