Study identification

PURI

https://redirect.ema.europa.eu/resource/47822

EU PAS number

EUPAS13328

Study ID

47822

Official title and acronym

Observational Serial Chart Review of Repatha® Use in European Subjects with Hyperlipidaemia (20130296)

DARWIN EU® study

No

Study countries

Austria
Belgium
Bulgaria
Germany
Greece
Italy
Poland
Portugal
Slovakia
Spain
Sweden
Switzerland

Study description

Review of clinical characteristics of patients who are prescribed Repatha and how their treatment is managed.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 250 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Amgen Inc
Study protocol
Initial protocol
English (1.11 MB - PDF)View document
Updated protocol
English (1.4 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable