Pulmonary Hypertension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: *Is aged 18 years or older at the time of screening for the previous study and has completed the required treatment duration with PF-07868469, as well as all other assessments at the end of that study. *Is willing and able to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion criteria
Exclusion criteria: *Has experienced worsening of PAH or has been hospitalized due to worsening PAH during the qualifying study. *Is scheduled for surgery to replace any tissue or part of the body (transplant), or has planned surgery related to PAH. *Has an ongoing major health issue during the qualifying study that, in the opinion of the study doctor, could disqualify the participant from this study. *Is currently suffering from, or has previously suffered from, hepato-pulmonary syndrome (a liver-related lung condition). *Is currently prescribed or taking medications known as GLP-1 agonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to week 111] *Number of Participants With Change From Baseline in Laboratory Tests Results [Time Frame: Baseline up to week 111] *Number of Participants With Vital Sign Abnormalities [Time Frame: Baseline up to week 111] | — |
Secondary
| Measure | Time frame |
|---|---|
| *Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration [Time Frame: Baseline up to week 104] *Minimum Observed Plasma Trough Concentration (Cmin), as data permits [Time Frame: Baseline up to week 111] *Incidence of Anti-Drug Antibody (ADA) [Time Frame: Baseline up to week 111] | — |
Countries
Australia, Belgium, Canada, China, Czechia, France, Germany, Greece, Italy, Japan, South Korea, Spain, United Kingdom, United States
Contacts
Pfizer R&D Japan G.K.