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| ID | Type | Description | Link |
|---|---|---|---|
| 7962-003 | Other Identifier | MSD | |
| 2020-004142-11 | EudraCT Number |
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The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study in subjects with symptomatic PAH who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug or toxin induced, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects (CHDs), and currently on background PAH therapy.
The primary efficacy endpoint of the study is exercise capacity, as measured by the 6-minute walk distance (6MWD) measured at 24 week following initiation of treatment.
Study duration will be approximately 2 years. A stratified Wilcoxon test will be used for analysis of the primary endpoint, with appropriate imputation for missing data, as detailed in the Statistical Analysis Plan. An unblinded, external, independent Data Monitoring Committee (DMC) will monitor participant safety throughout the course of the study. Participants completing this study will be eligible to receive sotatercept in a separate, open-label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept plus background PAH therapy | Experimental | Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy |
|
| Placebo plus background PAH therapy | Placebo Comparator | Placebo administered (SC) every 21 days plus background PAH therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). Per protocol, change from baseline in 6MWD at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who reported an AE were reported for DBPC period. | Up to approximately 24 weeks |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for DBPC period. | Up to approximately 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Multicomponent Improvement was defined as consisting of all of the following: (a) Improvement in 6MWD (increase ≥30 meters) (b) Improvement in N-terminal pro b-type natriuretic peptide (NT-proBNP; decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level <300 ng/L (c) Improvement in World Health Organization (WHO) Functional Class (FC) or maintenance of WHO FC II. Per protocol, change from baseline in the percentage of participants achieving multicomponent improvement at Week 24 was reported for DBPC period. |
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Key Inclusion Criteria:
Age ≥ 18 years
Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
Symptomatic PAH classified as WHO Functional Class (FC) II or III
Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of ≥ 5 Wood units (WU) and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg.
On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice
6-Minute Walk Distance (6MWD) ≥ 150 and ≤ 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
Females of childbearing potential must:
Key Exclusion Criteria:
Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group I should also include schistosomiasis associate PAH and pulmonary veno occlusive disease
Hemoglobin (Hgb) at screening above gender-specific upper limit of normal (ULN), per local laboratory test
Baseline platelet count < 50,000/mm^3 (< 50.0 x 109/L) at screening
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during screening visit after a period of rest
Baseline systolic blood pressure < 90 mmHg at screening
Pregnant or breastfeeding women
Any of the following clinical laboratory values at the screening visit:
Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
Prior exposure to sotatercept (ACE-011) or luspatercept (ACE 536) and/or excipients or known allergic reaction to either one
History of full pneumonectomy
Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing more than mild interstitial lung disease (ILD) at the screening visit or 1 year prior to it
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
History of more than mild obstructive sleep apnea that is untreated
Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
History of restrictive, constrictive or congestive cardiomyopathy
History of atrial septostomy within 180 days prior to the screening visit
Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the screening period
Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit
Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
Cerebrovascular accident within 3 months prior to the screening visit
Acutely decompensated heart failure within 30 days prior to the screening visit, as per investigator assessment
Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists (Site 1010) | Phoenix | Arizona | 85012 | United States | ||
| Pulmonary Associates, PA (Site 1008) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36877098 | Result | Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Souza R, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Xu Y, Miller B, Fowler M, Butler J, Koglin J, de Oliveira Pena J, Humbert M; STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6. | |
| 42246435 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Per protocol, not all participants from the double-blind placebo controlled (DBPC) period entered the long-term double blind (LTDB) period due to clinical worsening or consent withdrawal after DBPC period.
Of the 324 randomized participants, 1 participant was randomized in error and did not receive study treatment and no data was collected. Hence, the results are presented on 323 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotatercept Plus Background PAH Therapy | Participants received a starting dose of sotatercept 0.3 mg/kg titrated up to 0.7mg/kg by subcutaneous (SC) injection every 21 days plus background PAH therapy during the double-blind placebo controlled (DBPC) period for up to approximately 24 weeks. After 24 weeks, participants received sotatercept dose titrated up to 0.7mg/kg SC injection every 21 days plus background PAH therapy during the long-term double blind (LTDB) period for up to approximately 72 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Placebo Controlled (DBPC) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2021 |
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Participants will be randomized to one of two treatment arms to receive either sotatercept (0.7 mg/kg) by subcutaneous administration once every 3 weeks, or placebo. All participants will be on concurrent, stable background PAH therapy. Randomization will be stratified by baseline WHO Functional Class (Class II or III) and by background PAH therapy (mono/double or triple therapy)
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Study participants, care providers. Investigators and outcomes assessor will be masked to the study intervention until the final participant completes the 24-week efficacy assessment.
|
| Placebo | Drug | Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy. |
|
| Background PAH Therapy | Drug | Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist. |
|
| Baseline and Week 24 |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). Per protocol, the change from baseline in PVR at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is a circulating biomarker that reflects myocardial stretch. Per protocol, the change from baseline in NT-proBNP level at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, change from baseline in the percentage of participants who improve in WHO FC at Week 24 were reported for DBPC period. | Baseline and Week 24 |
| Time to Death or the First Occurrence of Clinical Worsening Event | Clinical Worsening events are defined as any of the following: worsening-related listing for lung and/or heart transplant; need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; need for atrial septostomy; hospitalization for worsening of PAH (≥ 24 hours); or deterioration of PAH defined by both of the following events occurring at any time: worsened WHO FC and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart, but no more than 1 week. Per protocol, time to death or the first occurrence of clinical worsening event was reported. | Up to approximately 18 months |
| Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24 | The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. Per protocol, change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Per protocol, change from baseline in the physical impacts domain score at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Per protocol, change from baseline in the cardiopulmonary domain score at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Per protocol, change from baseline in the cognitive/emotional impacts domain score at Week 24 was reported for DBPC period. | Baseline and Week 24 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| University of Arizona (Site 1006) | Tucson | Arizona | 85724 | United States |
| University of California San Diego Medical Center (Site 1002) | San Diego | California | 92037 | United States |
| University of California - Davis Medical Center (Site 1064) | Sherman Oaks | California | 95817 | United States |
| Stanford University Medical Center (Site 1024) | Stanford | California | 94305 | United States |
| Harbor UCLA Medical Center (Site 1028) | Torrance | California | 90502 | United States |
| University of Colorado Hospital (Site 1013) | Aurora | Colorado | 80045 | United States |
| The George Washington University Medical Faculty Associates (Site 1025) | Washington D.C. | District of Columbia | 20037 | United States |
| Mayo Clinic Jacksonville (Site 1045) | Jacksonville | Florida | 32256 | United States |
| University of South Florida (Site 1043) | Tampa | Florida | 33606 | United States |
| The Emory Clinic (Site 1030) | Atlanta | Georgia | 30322 | United States |
| Norton Pulmonary Specialists (Site 1066) | Louisville | Kentucky | 40202 | United States |
| Tufts Medical Center - PPDS (Site 1012) | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital (Site 1014) | Boston | Massachusetts | 02115 | United States |
| University of Michigan (Site 1011) | Ann Arbor | Michigan | 48109-5936 | United States |
| University of Minnesota (Site 1062) | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic (Site 1023) | Rochester | Minnesota | 55905 | United States |
| University of Kansas Medical Center (Site 1020) | Kansas City | Missouri | 66160-7232 | United States |
| Washington University School of Medicine (Site 1022) | St Louis | Missouri | 63110 | United States |
| Nebraska Medical Center (Site 1053) | Omaha | Nebraska | 68105 | United States |
| Renown Institute for Heart & Vascular Health (Site 1055) | Reno | Nevada | 89502-1262 | United States |
| New York Presbyterian Hospital (Site 1046) | New York | New York | 10032 | United States |
| Duke University Medical Center (Site 1026) | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center (Site 1035) | Cincinnati | Ohio | 45219-2316 | United States |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001) | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center (Site 1005) | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Wexner Medical Center (Site 1032) | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University (Site 1054) | Portland | Oregon | 97232 | United States |
| University of Pennsylvania (Site 1047) | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059) | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital (Site 1033) | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina - PPDS (Site 1003) | Charleston | South Carolina | 29425-8900 | United States |
| Statcare Pulmonary Consultants - Knoxville (Site 1031) | Knoxville | Tennessee | 37919 | United States |
| Vanderbilt University Medical Center (Site 1027) | Nashville | Tennessee | 37232 | United States |
| CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044) | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital (Site 1009) | Houston | Texas | 77030 | United States |
| University of Utah - PPDS (Site 1049) | Salt Lake City | Utah | 84132 | United States |
| University of Washington Medical Center - Montlake (Site 1067) | Seattle | Washington | 98195-0001 | United States |
| Hospital Universitario Austral ( Site 1901) | Pilar | Buenos Aires | B1629ODT | Argentina |
| Instituto de Investigaciones Clinicas Quilmes ( Site 1903) | Quilmes | Buenos Aires | B1878GEG | Argentina |
| Centro Medico Dra De Salvo ( Site 1904) | Buenos Aires | Buenos Aires F.D. | C1426ABP | Argentina |
| Sanatorio Parque ( Site 1905) | Rosario | Santa Fe Province | 2000 | Argentina |
| Hospital Provincial Dr. Jose M. Cullen ( Site 1902) | Santa Fe | S2732XAA | Argentina |
| Royal Prince Alfred Hospital ( Site 1106) | Camperdown | New South Wales | 2050 | Australia |
| Saint Vincents Hospital Sydney ( Site 1102) | Darlinghurst | New South Wales | 2010 | Australia |
| John Hunter Hospital ( Site 1101) | New Lambton | New South Wales | 2305 | Australia |
| Westmead Hospital ( Site 1105) | Westmead | New South Wales | 2145 | Australia |
| Prince Charles Hospital ( Site 1104) | Chermside | Queensland | 4032 | Australia |
| The Alfred Hospital ( Site 1110) | Melbourne | Victoria | 3004 | Australia |
| Hopital Erasme ( Site 1402) | Brussels | Bruxelles-Capitale, Region de | 1070 | Belgium |
| U.Z.-Gasthuisberg ( Site 1401) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805) | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Dia do Pulmao ( Site 1802) | Blumenau | Santa Catarina | 89030-101 | Brazil |
| Instituto do Coracao - HC FMUSP ( Site 1803) | São Paulo | 05403-000 | Brazil |
| University Of Alberta Hospital ( Site 2101) | Edmonton | Alberta | T6G 2E1 | Canada |
| University of Ottawa Heart Institute ( Site 2104) | Ottawa | Ontario | K1Y 4W7 | Canada |
| Jewish General Hospital ( Site 2103) | Montreal | Quebec | H3T 1E2 | Canada |
| Fakultni Nemocnice Olomouc ( Site 2203) | Olomouc | Olomouc Region | 779 00 | Czechia |
| Institut Klinicke a Experimentalni Mediciny ( Site 2202) | Prague | Praha 4 | 140 21 | Czechia |
| Vseobecna fakultni nemocnice v Praze ( Site 2201_ | Prague | Praha, Hlavni Mesto | 128 08 | Czechia |
| Hopital Pasteur (Site 1311) | Nice | Alpes-Maritimes | 06002 | France |
| Hopitaux Universitaires de Strasbourg ( Site 1307) | Strasbourg | Bas-Rhin | 67000 | France |
| CHRU Brest - Hopital Cavale Blanche (Site 1314) | Brest | Finistere | 29609 | France |
| Groupe Hospitalier Sud ( Site 1312) | Pessac | Gironde | 33604 | France |
| CHU de Toulouse - Hopital Larrey ( Site 1315) | Toulouse | Haute-Garonne | 31059 | France |
| Hopital Arnaud de Villeneuve ( Site 1301) | Montpellier | Herault | 34090 | France |
| CHU de Grenoble - Hopital Michallon ( Site 1303) | Grenoble | Isere | 38043 | France |
| CHU Nantes - Hopital Laennec (Site 1309) | Nantes | Loire-Atlantique | 44093 | France |
| CHU Angers (Site 1313) | Angers | Maine-et-Loire | 49100 | France |
| C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| CHRU Lille ( Site 1306) | Lille | Nord | 59037 | France |
| Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) | Saint-Priest-en-Jarez | Pays de la Loire Region | 42055 | France |
| Centre Hospitalier Universitaire de Bicetre ( Site 1304) | Le Kremlin-Bicêtre | Val-de-Marne | 94270 | France |
| Thoraxklinik-Heidelberg gGmbH (Site 1509) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Krankenhaus Neuwittelsbach (Site 1510) | Munich | Bavaria | 80639 | Germany |
| Universitaetsklinik Regensburg (Site 1503) | Regensburg | Bavaria | 93053 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512) | Giessen | Hesse | 35392 | Germany |
| Medizinische Hochschule Hannover (Site 1505) | Hanover | Lower Saxony | 30625 | Germany |
| Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511) | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501) | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Halle (Site 1502) | Halle | Saxony-Anhalt | 06120 | Germany |
| DRK Kliniken Berlin Westend ( Site 1507) | Berlin | 14050 | Germany |
| Lady Davis Carmel Medical Center (Site 1705) | Haifa | 34362 | Israel |
| Meir Medical Center (Site 1707) | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center (Site 1703) | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center (Site 1701) | Tel Litwinsky | 5265601 | Israel |
| Universita "La Sapienza" Policlinico Umberto I (Site 2402) | Roma | 00161 | Italy |
| CIMAB SA de CV (Site 2502) | Torreón | Coahuila | 27000 | Mexico |
| Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505) | Monterrey | Nuevo León | 64718 | Mexico |
| Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501) | Huixquilucan | 52763 | Mexico |
| Maastricht University Medical Center (Site 2603) | Maastricht | Limburg | 6229 HX | Netherlands |
| VU Medisch Centrum (Site 2601) | Amsterdam | North Holland | 1081 HV | Netherlands |
| University of Otago, Wellington (Site 2701) | Christchurch | Canterbury | 8011 | New Zealand |
| Waikato District Health Board (Site 2702) | Hamilton | Waikato Region | 3204 | New Zealand |
| Greenlane Clinical Centre (Site 2703) | Auckland | 1051 | New Zealand |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801) | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802) | Otwock | Masovian Voivodeship | 05-400 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803) | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Clinical Center of Serbia (Site 2901) | Belgrade | Beograd | 11000 | Serbia |
| Institute of Cardiovascular Diseases Dedinje (Site 2903) | Belgrade | Beograd | 116550 | Serbia |
| University Clinical Center Nis (Site 2904) | Niš | Nisavski Okrug | 1800 | Serbia |
| Gachon University Gil Medical Center (Site 3103) | Incheon | 21565 | South Korea |
| Seoul National University Hospital (Site 3102) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS (Site 3101) | Seoul | 03722 | South Korea |
| Hospital Universitario Marques de Valdecilla (Site 1601) | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604) | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Vall d'Hebron (Site 1605) | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona (Site 1602) | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon y Cajal (Site 1609) | Madrid | 28034 | Spain |
| Hospital Universitario Marques de Valdecilla (Site 1603) | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Salamanca (Site 1608) | Salamanca | 37007 | Spain |
| Akademiska Sjukhuset (Site 3204) | Uppsala | Uppsala County | 751 85 | Sweden |
| Sahlgrenska Universitets Sjukhuset (Site 3201) | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Hopitaux Universitaires de Geneve HUG (Site 3302) | Thônex | Canton of Geneva | 1226 | Switzerland |
| Universitaetsspital Zuerich (Site 3301) | Zurich | 8091 | Switzerland |
| Golden Jubilee National Hospital (Site 1204) | Glasgow | Glasgow City | G81 4DY | United Kingdom |
| Royal Free London NHS Foundation Trust (Site 1202) | London | London, City of | NW3 2QG | United Kingdom |
| Royal Brompton Hospital (Site 1206) | London | London, City of | SW3 6NP | United Kingdom |
| Imperial College Healthcare NHS Trust (Site 1203) | London | London, City of | W12 0HS | United Kingdom |
| Derived |
| Dutta S, Shah R, Singhal S, Singh M, Dholariya S, Chawla S, Katoch C. A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension. Expert Opin Drug Saf. 2026 Jun 9:1-13. doi: 10.1080/14740338.2026.2685360. Online ahead of print. |
| 40526255 | Derived | Alsumali A, McLaughlin V, Chevure J, Klok R, Zhang W, Martinez EC, Pausch C, De Oliveira Pena J, van de Wetering G, Jootun M, Lautsch D, Hoeper MM. Long-Term Mortality and Morbidity Impact on Patients with Pulmonary Arterial Hypertension (PAH) If Access to Sotatercept Is Delayed: A Simulation Model. Adv Ther. 2025 Aug;42(8):3902-3921. doi: 10.1007/s12325-025-03241-4. Epub 2025 Jun 17. |
| 37851297 | Derived | McLaughlin V, Alsumali A, Liu R, Klok R, Martinez EC, Nourhussein I, Bernotas D, Chevure J, Pausch C, De Oliveira Pena J, Lautsch D, Hoeper MM. Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). Adv Ther. 2024 Jan;41(1):130-151. doi: 10.1007/s12325-023-02684-x. Epub 2023 Oct 18. |
| 37696565 | Derived | Souza R, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Lin J, Johnson-Levonas AO, de Oliveira Pena J, Humbert M, Hoeper MM. Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial. Eur Respir J. 2023 Sep 21;62(3):2301107. doi: 10.1183/13993003.01107-2023. Print 2023 Sep. |
| Plain Language Summary | View source |
| FG001 | Placebo Plus Background PAH Therapy | Participants received dose matched placebo by SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks and the LTDB period for up to approximately 72 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Long Term Double Blind (LTDB) |
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Of the 324 participants randomized in the study, one participant was randomized in error in placebo plus background PAH therapy arm and no data was collected on this participant. Per protocol, this participant was excluded from the study analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sotatercept Plus Background PAH Therapy | Participants received a starting dose of sotatercept 0.3 mg/kg titrated up to 0.7mg/kg by subcutaneous (SC) injection every 21 days plus background PAH therapy during the double-blind placebo controlled (DBPC) period for up to approximately 24 weeks. After 24 weeks, participants received sotatercept dose titrated up to 0.7mg/kg SC injection every 21 days plus background PAH therapy during the long-term double blind (LTDB) period for up to approximately 72 weeks. |
| BG001 | Placebo Plus Background PAH Therapy | Participants received dose matched placebo by SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks and the LTDB period for up to approximately 72 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 6-Minute Walk Distance (6MWD) at baseline | The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. | Mean | Standard Deviation | meters |
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| World Health Organization (WHO) functional class (FC) II or III at baseline | WHO FC was used to rate how ill a pulmonary arterial hypertension (PAH) participant was. Class II: Participants with PAH resulting in a slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope. Class III: Participants with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope | Count of Participants | Participants |
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| Background PAH Therapy at Baseline | Background PAH therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy (double or triple therapy) with endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). Per protocol, change from baseline in 6MWD at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and had a baseline value of 6MWD. | Posted | Median | Full Range | meters | Baseline and Week 24 |
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| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who reported an AE were reported for DBPC period. | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 24 weeks |
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| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for DBPC period. | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 24 weeks |
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| Secondary | Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Multicomponent Improvement was defined as consisting of all of the following: (a) Improvement in 6MWD (increase ≥30 meters) (b) Improvement in N-terminal pro b-type natriuretic peptide (NT-proBNP; decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level <300 ng/L (c) Improvement in World Health Organization (WHO) Functional Class (FC) or maintenance of WHO FC II. Per protocol, change from baseline in the percentage of participants achieving multicomponent improvement at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the multicomponent improvement. | Posted | Number | Percent change | Baseline and Week 24 |
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| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). Per protocol, the change from baseline in PVR at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the PVR. | Posted | Median | Full Range | dynes*sec/cm^5 | Baseline and Week 24 |
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| Secondary | Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is a circulating biomarker that reflects myocardial stretch. Per protocol, the change from baseline in NT-proBNP level at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the NT-proBNP levels. | Posted | Median | Full Range | pg/mL | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, change from baseline in the percentage of participants who improve in WHO FC at Week 24 were reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the WHO FC. | Posted | Number | Percent change | Baseline and Week 24 |
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| Secondary | Time to Death or the First Occurrence of Clinical Worsening Event | Clinical Worsening events are defined as any of the following: worsening-related listing for lung and/or heart transplant; need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; need for atrial septostomy; hospitalization for worsening of PAH (≥ 24 hours); or deterioration of PAH defined by both of the following events occurring at any time: worsened WHO FC and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart, but no more than 1 week. Per protocol, time to death or the first occurrence of clinical worsening event was reported. | All randomized participants who received at least one dose of study treatment and who died or experienced a first clinical worsening event. | Posted | Median | Standard Deviation | Weeks | Up to approximately 18 months |
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| Secondary | Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24 | The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. Per protocol, change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the low risk score. | Posted | Number | Percent Change | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Per protocol, change from baseline in the physical impacts domain score at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline physical impact domain score. | Posted | Median | Full Range | Score on a scale | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Per protocol, change from baseline in the cardiopulmonary domain score at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline cardiopulmonary domain score. | Posted | Median | Full Range | Score on a scale | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Per protocol, change from baseline in the cognitive/emotional impacts domain score at Week 24 was reported for DBPC period. | All randomized participants who received at least one dose of study treatment and who had a baseline cognitive/emotional impacts domain score. | Posted | Median | Full Range | Score on a scale | Baseline and Week 24 |
|
Up to approximately 19 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotatercept Plus Background PAH Therapy (DBPC Period) | Participants received a starting dose of sotatercept 0.3 mg/kg titrated up to 0.7mg/kg by subcutaneous (SC) injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. | 0 | 163 | 23 | 163 | 111 | 163 |
| EG001 | Placebo Plus Background PAH Therapy (DBPC Period) | Participants received dose matched placebo SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. | 6 | 160 | 36 | 160 | 88 | 160 |
| EG002 | Sotatercept Plus Background PAH Therapy (LTDB Period) | Participants received sotatercept dose titrated up to 0.7mg/kg SC injection every 21 days plus background PAH therapy during the LTDB period for up to approximately 72 weeks. | 2 | 159 | 26 | 158 | 82 | 158 |
| EG003 | Placebo Plus Background PAH Therapy (LTDB Period) | Participants received dose matched placebo SC injection every 21 days plus background PAH therapy during the LTDB period for up to approximately 72 weeks. | 1 | 142 | 14 | 142 | 50 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Right ventricular failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Complication associated with device | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Vascular device occlusion | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
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| Sarcoidosis | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Perineal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sepsis syndrome | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Vascular device infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Neck injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Myocardial necrosis marker increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Device dislocation | Product Issues | MedDRA 25.0 | Systematic Assessment |
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| Device leakage | Product Issues | MedDRA 25.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 25.0 | Systematic Assessment |
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| Device occlusion | Product Issues | MedDRA 25.0 | Systematic Assessment |
| |
| Device physical property issue | Product Issues | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary artery aneurysm | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jul 18, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| 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
| Protocol Violation |
|
| Death |
|
| Sponsor decision |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Class III |
|
| Double therapy |
|
| Triple therapy |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
|
|
|
|
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Participants received dose matched placebo by SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks and the LTDB period for up to approximately 72 weeks.
|
|
|
|
|
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Participants received dose matched placebo SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. |
|
|
|
Participants received dose matched placebo SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. |
|
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Participants received dose matched placebo SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks.
|
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|