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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521155-23-00 | Registry Identifier | CTIS (EU) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Participants will receive subcutaneous doses of PF-07868489 every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07868489 | Drug | Participants will receive subcutaneous doses of PF-07868489 every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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This study is seeking participants who are:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health Medical Center | Not yet recruiting | Sacramento | California | 95817 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| 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 |
| UCSF Health St. Mary's Hospital |
| Recruiting |
| San Francisco |
| California |
| 94117 |
| United States |
| Heart and Vascular Center | Recruiting | San Francisco | California | 94143 | United States |
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| Norton Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Pulmonary Specialists | Recruiting | Louisville | Kentucky | 40202 | United States |
| Mount Sinai Hospital | Not yet recruiting | New York | New York | 10029 | United States |
| Clinical Trials Unit at Eastowne Medical Office Building | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Pulmonary Hypertension Clinical Trials Office at Eastowne | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Pulmonary Specialty Clinic at Eastowne Medical Office Building | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| UNC Hospitals | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
| Center for Advanced Lung Care | Recruiting | Providence | Rhode Island | 02904 | United States |
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Pulmonary Hypertension Research Queensland Pty Ltd | Recruiting | Auchenflower | Queensland | 4066 | Australia |
| HUB Hôpital Erasme | Recruiting | Brussels | 1070 | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| London Health Sciences Centre - University Hospital | Not yet recruiting | London | Ontario | N6A 5A5 | Canada |
| London Health Sciences Centre | Not yet recruiting | London | Ontario | N6A 5W9 | Canada |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
| CHRU de Brest | Recruiting | Brest | Finistère | 29200 | France |
| Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord | Recruiting | Saint-Priest-en-Jarez | 42055 | France |
| Thoraxklinik-Heidelberg gGmbH | Recruiting | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Universitätsklinikum Regensburg | Recruiting | Regensburg | Bavaria | 93053 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Recruiting | Giessen | Hesse | 35392 | Germany |
| Universitätsmedizin Greifswald | Recruiting | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Recruiting | Chaïdári | Attica | 12461 | Greece |
| Onassis Hospital | Not yet recruiting | Kallithea | Attica | 17674 | Greece |
| AHEPA University General Hospital of Thessaloniki | Recruiting | Thessaloniki | Central Macedonia | 54636 | Greece |
| Fondazione IRCCS San Gerardo dei Tintori | Not yet recruiting | Monza | Monza E Brianza | 20900 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
| Kobe University Hospital | Recruiting | Kobe | Hyōgo | 650-0017 | Japan |
| St. Marianna University Hospital | Recruiting | Kawasaki | Kanagawa | 216-8511 | Japan |
| Tohoku University Hospital | Not yet recruiting | Sendai | Miyagi | 980-8574 | Japan |
| National Hospital Organization Okayama Medical Center | Recruiting | Okayama | 701-1192 | Japan |
| Gachon University Gil Medical Center | Recruiting | Incheon | Incheon-gwangyeoksi [incheon] | 21565 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 06351 | South Korea |
| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hammersmith Hospital | Recruiting | London | Greater London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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