C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension

Condition studied

Pulmonary Arterial Hypertension

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence and severity of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)., Incidence of related treatment emergent AEs (TEAEs) & treatment emergent SAEs (TESAEs)., Change from baseline in vital signs., Change from baseline in clinical laboratory values., Change from baseline in electrocardiogram (ECG) parameters (heart rate, QT, QTc corrected using Fridericia’s formula (QTcF), PR, and QRS intervals).

Endpoint detail

Change from baseline in NT-pro-BNP., PF-07868489 PK parameters after repeat doses; as data permit: minimum plasma concentration (Cmin)., Incidence of the development of antidrug antibody (ADA) against PF-07868489 following repeat doses.