Post-authorisation Safety Study (PASS): Retrospective Medical Chart Review of Patients with PAH Newly Treated With Either Uptravi® (selexipag) or any Other PAH-specific Therapy (EXTRACT)

Study identification

• EU PAS number:
  EUPAS49227
• Study ID:
  103768
• Official title and acronym:
  Post-authorisation Safety Study (PASS): Retrospective Medical Chart Review of Patients with PAH Newly Treated With Either Uptravi® (selexipag) or any Other PAH-specific Therapy (EXTRACT)
• DARWIN EU® study:
  No
• Study countries:
  Lithuania

  Netherlands

  Slovakia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Actelion Pharmaceuticals

University of Calgary Calgary, Canada, Saint Jopseph Healthcare Hamilton, Canada, Vancouver General Hospital Vancouver, Canada, PAH Center VFN Prague General University Hospital Prague, Czeck Republic, CHU Nice Hopital Pasteur Nice, France, Ospedale San Bortolo Vicenza, Italy, Vilnius University Hospital - Santaros Klinikos Vilnius, Lithuania, Uniwersyteckie Centrum Kliniczne Gdansk, Poland, Europejskie Centrum Zdrowia Otwock, Poland, Vychodoslovensky ustav srdcovych a cievnych chorob (VUSCH) Kosice. Slovakia

Study timelines

Date when funding contract was signed

Planned:20/10/2021

Actual:20/10/2021

Study start date

Planned:28/02/2023

Actual:10/02/2023

Date of final study report

Planned:29/03/2024

Actual:07/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actelion Pharmaceuticals Ltd, a Janssen pharmaceutical company of Johnson and Johnson

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)

Other study registration identification numbers and links

67896049PAH0002