Protocol AC-065A403 - PASS- Uptravi titration - Educate
Research type
Research Study
Full title
AC-065A403: Post-authorisation safety study (PASS) to evaluate risk minimisation measures for medication errors with Uptravi during the titration phase in patients with pulmonary arterial hypertension (PAH) in clinical practice.
IRAS ID
314273
Contact name
Luke Howard
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Duration of Study in the UK
1 years, 5 months, days
Research summary
Pulmonary arterial hypertension (PAH) is a rare, severe and progressive disease ultimately leading to right heart failure and death. Uptravi (selexipag) is an orally available selective IP receptor agonist approved in the European Union. Uptravi is indicated for the long-term treatment of PAH in adult patients with World Health Organisation functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist and/or a phosphodiesterase Type 5 inhibitor, or as monotherapy in patients who are not candidates for these therapies. the objective on this study is to assess whether the titration guide and titration pack for Uptravi treatment in PAH are easy to understand and use for patients and health care professionals. This is not part of a marketing study but is a scientific study conducted at the request of the European Medicines Agency.
REC name
London - Surrey Research Ethics Committee
REC reference
22/PR/0770
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion