Study identification

PURI

https://redirect.ema.europa.eu/resource/39607

EU PAS number

EUPAS7795

Study ID

39607

Official title and acronym

Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Novartis Clinical Disclosure Officer

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 Pharma AG
Study protocol
Initial protocol

QVA149A2401-v03--protocol_2_Redacted

English (1.19 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 3 (required)