A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489
- Registration Number
- NCT07073820
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart.
This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label PF-07868489 Participants will receive subcutaneous doses of PF-07868489 every 4 weeks
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to week 111 Number of Participants With Change From Baseline in Laboratory Tests Results Baseline up to week 111 Number of Participants With Vital Sign Abnormalities Baseline up to week 111
- Secondary Outcome Measures
Name Time Method Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters Baseline up to week 111 Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration Baseline up to week 104 Minimum Observed Plasma Trough Concentration (Cmin), as data permits Baseline up to week 111 Incidence of Anti-Drug Antibody (ADA) Baseline up to week 111