Study identification

PURI

https://redirect.ema.europa.eu/resource/39254

EU PAS number

EUPAS10446

Study ID

39254

Official title and acronym

Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury

DARWIN EU® study

No

Study countries

Denmark
Germany
Spain
Sweden

Study description

This is a large, multinational, longitudinal retrospective cohort and nested case-control study using 5 European databases aiming at comparing the risk of hospitalisation for acute liver injury (ALI) in patients initiating treatment with agomelatine and other antidepressants with the risk in patients initiating treatment with citalopram used as a common reference group.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Southern Denmark University Denmark

Contact details

Manel Pladevall

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

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

More details on funding

Les Laboratoires Servier
Study protocol
Initial protocol

PASS_Final protocol_22July2015_redacted

English (1.02 MB - PDF)View document
Updated protocol

PASS_ Final Protocol_18May2017_redacted

English (1.1 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)