Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-7962-023 | Other Identifier | MSD | |
| U1111-1309-2142 | Registry Identifier | UTN | |
| 2024-515773-99-00 | Registry Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept 0.3 mg/kg | Experimental | Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation. |
|
| Sotatercept 0.7 mg/kg | Experimental | Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to approximately 187 weeks |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 168 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48 | PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Week 48 will be presented. | Baseline and Week 48 |
| Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48 |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment [EOT] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA ( Site 1008) | Phoenix | Arizona | 85032 | United States | ||
| Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004) |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 48 will be presented. |
| Baseline and Week 48 |
| Change From Baseline in the 6MWD at Week 126 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 126 will be presented. | Baseline and Week 126 |
| Change From Baseline in the 6MWD at Week 174 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 174 will be presented. | Baseline and Week 174 |
| Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 48 will be presented. | Baseline and Week 48 |
| Change From Baseline in NYHA FC at Week 126 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 126 will be presented. | Baseline and Week 126 |
| Change From Baseline in NYHA FC at Week 174 | NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 174 will be presented. | Baseline and Week 174 |
| Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 48. The change from baseline in NT-proBNP at Week 48 will be presented. | Baseline and Week 48 |
| Change From Baseline in NT-proBNP at Week 126 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 126. The change from baseline in NT-proBNP at Week 126 will be presented. | Baseline and Week 126 |
| Change From Baseline in NT-proBNP at Week 174 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 174. The change from baseline in NT-proBNP at Week 174 will be presented. | Baseline and Week 174 |
| Change From Week 24 in PVR at Week 48 | PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from Week 24 in PVR at Week 48 will be presented. | Week 24 and Week 48 |
| Change From Week 24 in 6MWD at Week 48 | The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from Week 24 in 6MWD at Week 48 will be presented. | Week 24 and Week 48 |
| Change From Week 24 in NYHA FC at Week 48 | NYHA FC classifies the extent of heart failure. The change from Week 24 in NYHA FC at Week 48 will be presented. | Week 24 and Week 48 |
| La Jolla |
| California |
| 92037 |
| United States |
| Jeffrey S. Sager, MD Medical Corporation ( Site 1060) | Santa Barbara | California | 93105 | United States |
| Stanford University Medical Center ( Site 1024) | Stanford | California | 94305 | United States |
| South Denver Cardiology Associates ( Site 1091) | Littleton | Colorado | 80120 | United States |
| Yale New Haven Hospital ( Site 1093) | New Haven | Connecticut | 06520 | United States |
| AdventHealth Orlando ( Site 1058) | Orlando | Florida | 32803 | United States |
| The Emory Clinic ( Site 1030) | Atlanta | Georgia | 30322 | United States |
| Norton Pulmonary Specialists ( Site 1066) | Louisville | Kentucky | 40202 | United States |
| University Of Nebraska Medical Center ( Site 1053) | Omaha | Nebraska | 68198 | United States |
| Weill Cornell Medical Center ( Site 1046) | New York | New York | 10065 | United States |
| Duke University Medical Center ( Site 1026) | Durham | North Carolina | 27710-4000 | United States |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation. ( Site 1065) | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center ( Site 1032) | Columbus | Ohio | 43210 | United States |
| Allegheny General Hospital ( Site 1088) | Pittsburgh | Pennsylvania | 15212-4737 | United States |
| Lankenau Medical Center ( Site 1089) | Wynnewood | Pennsylvania | 19096 | United States |
| Rhode Island Hospital ( Site 1039) | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina ( Site 1003) | Charleston | South Carolina | 29425 | United States |
| Statcare Pulmonary Consultants ( Site 1031) | Knoxville | Tennessee | 37919 | United States |
| Intermountain Medical Center ( Site 1079) | Murray | Utah | 84107 | United States |
| Inova Fairfax Medical Campus ( Site 1078) | Falls Church | Virginia | 22042 | United States |
| Pulmonary Associates of Richmond - West Broad Street ( Site 1069) | Richmond | Virginia | 23230 | United States |
| Université Libre de Bruxelles - Hôpital Erasme ( Site 0100) | Brussels | Bruxelles-Capitale, Region de | 1070 | Belgium |
| Hamilton Health Sciences Hamilton General Hospital ( Site 0004) | Hamilton | Ontario | L8L 2X2 | Canada |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206) | Nice | Alpes-Maritimes | 06000 | France |
| Hopital Arnaud de Villeneuve ( Site 0200) | Montpellier | Herault | 34295 | France |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205) | Saint-Herblain | Loire-Atlantique | 44800 | France |
| Centre Hopitalier Universitaire d'Angers ( Site 0204) | Angers | Maine-et-Loire | 49100 | France |
| CHU de Rouen ( Site 0203) | Rouen | Seine-Maritime | 76031 | France |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202) | Le Kremlin-Bicêtre | Val-de-Marne | 94270 | France |
| Thoraxklinik-Heidelberg gGmbH ( Site 0309) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Krankenhaus Neuwittelsbach ( Site 0310) | München | Bavaria | 80639 | Germany |
| UKGM Gießen/Marburg ( Site 0312) | Giessen | Hesse | 35392 | Germany |
| Universitaetsklinikum Koeln ( Site 0311) | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315) | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301) | Dresden | Saxony | 01307 | Germany |
| DRK Kliniken Berlin Westend ( Site 0307) | Berlin | 14050 | Germany |
| Rambam Health Care Campus ( Site 0403) | Haifa | 3109601 | Israel |
| Edith Wolfson Medical Center ( Site 0404) | Holon | 5810001 | Israel |
| Hadassah Medical Center ( Site 0402) | Jerusalem | 9112001 | Israel |
| Meir Medical Center ( Site 0401) | Kfar Saba | 4428164 | Israel |
| ZIV Medical Center ( Site 0400) | Safed | 1311001 | Israel |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502) | Bergamo | Lombardy | 24127 | Italy |
| Fondazione IRCCS Policlinico San Matteo ( Site 0501) | Pavia | 27100 | Italy |
| AOU Policlinico Umberto I ( Site 0500) | Roma | 00161 | Italy |
| Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505) | Monterrey | Nuevo León | 64718 | Mexico |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600) | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601) | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603) | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Hospital Costa del Sol ( Site 0704) | Marbella | Malaga | 29603 | Spain |
| Hospital Clinic I Provincial de Barcelona ( Site 0701) | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre ( Site 0702) | Madrid | 28041 | Spain |
| Hospital Universitario Virgen Macarena ( Site 0705) | Seville | 41009 | Spain |
| HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703) | Toledo | 45007 | Spain |
| Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800) | Gothenburg | Västra Götaland County | 413 46 | Sweden |
| Hammersmith Hospital-Department of Cardiology ( Site 0900) | London | London, City of | W12 OHS | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542017 | ACE-011 |
Not provided
Not provided
Not provided