Long-term safety and effects of PF-07868489 for people with pulmonary arterial hypertension who previously took the medicine
A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
This open-label extension tests whether continuing PF-07868489 is safe and tolerable long-term for adults with pulmonary arterial hypertension who completed an earlier PF-07868489 study.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 47 sites (San Francisco, California and 46 other locations) |
| Trial ID | NCT07073820 on ClinicalTrials.gov |
What this trial studies
This open-label extension enrolls adults with pulmonary arterial hypertension who completed a qualifying PF-07868489 study to collect long-term safety, tolerability, and effect data. Participants continue to receive PF-07868489 and attend scheduled clinic visits for clinical assessments, laboratory tests, and monitoring for adverse events. The trial excludes people who had worsening PAH or hospitalization during the qualifying study, those planning transplants or PAH surgeries, and those taking GLP-1 agonists. Data will be used to characterize long-term side effects and the durability of any benefits seen in earlier trials.
Who should consider this trial
Good fit: Adults (age ≥18) with pulmonary arterial hypertension who completed the required treatment and assessments in a prior PF-07868489 study, did not worsen or require hospitalization during that study, and can attend regular visits are ideal candidates.
Not a fit: People who did not participate in a prior PF-07868489 study, who experienced worsening or hospitalization for PAH in the qualifying study, who require or plan transplants or PAH surgery, or who are taking GLP-1 agonists are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the trial could clarify the long-term safety profile of PF-07868489 and support its continued use for people with PAH.
How similar studies have performed: Open-label extension studies of other PAH therapies have previously been used to collect long-term safety and tolerability data, but long-term results specific to PF-07868489 remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
This study is seeking participants who are: * aged 18 years or older at screening of the previous study and completed the required treatment duration with PF-07868469 and other assessments at the end of that study. * willing and able to abide with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * do not have worsening or hospitalization for worsening PAH during the qualifying study. * not on placement for a surgery to replace any tissue or part of the body (transplant), and planned surgery for PAH. * do not have an ongoing major health issue in the qualifying study, which in the opinion of the study doctor could make the participant not qualify for this study. * not suffering from or in the past have suffered from hepato-pulmonary syndrome (liver-related lung problem). * not currently prescribed or taking medicines called as GLP-1 agonist.
Where this trial is running
San Francisco, California and 46 other locations
- UCSF Health St. Mary's Hospital — San Francisco, California, United States (Recruiting)
- Heart and Vascular Center — San Francisco, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Norton Hospital — Louisville, Kentucky, United States (Recruiting)
- Norton Pulmonary Specialists — Louisville, Kentucky, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Not_yet_recruiting)
- Clinical Trials Unit at Eastowne Medical Office Building — Chapel Hill, North Carolina, United States (Recruiting)
- Pulmonary Hypertension Clinical Trials Office at Eastowne — Chapel Hill, North Carolina, United States (Recruiting)
- Pulmonary Specialty Clinic at Eastowne Medical Office Building — Chapel Hill, North Carolina, United States (Recruiting)
- UNC Hospitals — Chapel Hill, North Carolina, United States (Recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- Center for Advanced Lung Care — Providence, Rhode Island, United States (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Pulmonary Hypertension Research Queensland Pty Ltd — Auchenflower, Queensland, Australia (Recruiting)
- HUB Hôpital Erasme — Brussels, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- London Health Sciences Centre - University Hospital — London, Ontario, Canada (Not_yet_recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Vseobecna fakultni nemocnice v Praze — Prague, Czechia (Recruiting)
- CHRU de Brest — Brest, Finistère, France (Recruiting)
- Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord — Saint-Priest-en-Jarez, France (Recruiting)
- Thoraxklinik-Heidelberg gGmbH — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Universitätsklinikum Regensburg — Regensburg, Bavaria, Germany (Recruiting)
- Universitaetsklinikum Giessen und Marburg GmbH — Giessen, Hesse, Germany (Recruiting)
- Universitätsmedizin Greifswald — Greifswald, Mecklenburg-Vorpommern, Germany (Recruiting)
- Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden — Dresden, Saxony, Germany (Recruiting)
- University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" — Chaïdári, Attica, Greece (Recruiting)
- Onassis Hospital — Kallithea, Attica, Greece (Not_yet_recruiting)
- AHEPA University General Hospital of Thessaloniki — Thessaloniki, Central Macedonia, Greece (Recruiting)
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Monza E Brianza, Italy (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
- Kobe University Hospital — Kobe, Hyōgo, Japan (Recruiting)
- St. Marianna University Hospital — Kawasaki, Kanagawa, Japan (Recruiting)
- Tohoku University Hospital — Sendai, Miyagi, Japan (Not_yet_recruiting)
- National Hospital Organization Okayama Medical Center — Okayama, Japan (Recruiting)
- Gachon University Gil Medical Center — Incheon, Incheon-gwangyeoksi [incheon], South Korea (Recruiting)
- Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea (Recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi [seoul], South Korea (Recruiting)
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea (Recruiting)
- Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Madrid, Comunidad de, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hammersmith Hospital — London, Greater London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.