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Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.
Official title: A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-04-16
Completion Date
2029-03-30
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Sotatercept
subcutaneous injection
Locations (56)
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Stanford University Medical Center ( Site 1024)
Stanford, California, United States
South Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, United States
Yale New Haven Hospital ( Site 1093)
New Haven, Connecticut, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
The Emory Clinic ( Site 1030)
Atlanta, Georgia, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
Duke University Medical Center ( Site 1026)
Durham, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation. ( Site 1065)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 1089)
Wynnewood, Pennsylvania, United States
Rhode Island Hospital ( Site 1039)
Providence, Rhode Island, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Statcare Pulmonary Consultants ( Site 1031)
Knoxville, Tennessee, United States
Intermountain Medical Center ( Site 1079)
Murray, Utah, United States
Inova Fairfax Medical Campus ( Site 1078)
Falls Church, Virginia, United States
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
Richmond, Virginia, United States
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
Brussels, Bruxelles-Capitale, Region de, Belgium
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
Hamilton, Ontario, Canada
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
Nice, Alpes-Maritimes, France
Hopital Arnaud de Villeneuve ( Site 0200)
Montpellier, Herault, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
Saint-Herblain, Loire-Atlantique, France
Centre Hopitalier Universitaire d'Angers ( Site 0204)
Angers, Maine-et-Loire, France
CHU de Rouen ( Site 0203)
Rouen, Seine-Maritime, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
Le Kremlin-Bicêtre, Val-de-Marne, France
Thoraxklinik-Heidelberg gGmbH ( Site 0309)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 0310)
München, Bavaria, Germany
UKGM Gießen/Marburg ( Site 0312)
Giessen, Hesse, Germany
Universitaetsklinikum Koeln ( Site 0311)
Cologne, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)
Dresden, Saxony, Germany
DRK Kliniken Berlin Westend ( Site 0307)
Berlin, Germany
Rambam Health Care Campus ( Site 0403)
Haifa, Israel
Edith Wolfson Medical Center ( Site 0404)
Holon, Israel
Hadassah Medical Center ( Site 0402)
Jerusalem, Israel
Meir Medical Center ( Site 0401)
Kfar Saba, Israel
ZIV Medical Center ( Site 0400)
Safed, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
Bergamo, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo ( Site 0501)
Pavia, Italy
AOU Policlinico Umberto I ( Site 0500)
Roma, Italy
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
Monterrey, Nuevo León, Mexico
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)
Krakow, Lesser Poland Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)
Bialystok, Podlaskie Voivodeship, Poland
Hospital Costa del Sol ( Site 0704)
Marbella, Malaga, Spain
Hospital Clinic I Provincial de Barcelona ( Site 0701)
Barcelona, Spain
Hospital Universitario 12 de Octubre ( Site 0702)
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 0705)
Seville, Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
Toledo, Spain
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
Gothenburg, Västra Götaland County, Sweden
Hammersmith Hospital-Department of Cardiology ( Site 0900)
London, London, City of, United Kingdom