Pulmonary Arterial Hypertension
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGPF-07868489
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium, Czechia, France, Germany, Greece, Italy, Spain
Outcome results
None listed