Study identification

PURI

https://redirect.ema.europa.eu/resource/48403

EU PAS number

EUPAS19085

Study ID

48403

Official title and acronym

Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi (selexipag) or any other PAH-specific therapy, in clinical practice (EXPOSURE)

DARWIN EU® study

No

Study countries

Austria
Belgium
Canada
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Ireland
Italy
Lithuania
Netherlands
Poland
Portugal
Russian Federation
Slovakia
Spain
Sweden
Switzerland
United Kingdom

Study description

This prospective observational cohort study is conducted to further characterise the safety profile of Uptravi and to describe clinical characteristics and outcomes of patients newly treated with Uptravi in the post-marketing setting. A cohort of patients newly treated with any other PAH-specific therapy than Uptravi and who were never treated with Uptravi is included in this study for the purpose of comparing the incidence of major adverse cardiovascular events (MACE) and all-cause death with patients newly treated with Uptravi.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Audrey Muller

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Actelion Pharmaceuticals Ltd.
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)