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| ID | Type | Description | Link |
|---|---|---|---|
| A011-14 | Other Identifier | Acceleronpharma | |
| MK-7962-006 | Other Identifier | MSD | |
| 2023-509140-10-00 | Registry Identifier | EU CT | |
| U1111-1309-6376 | Registry Identifier | UTN | |
| 2021-001498-21 | EudraCT Number |
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The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension [PAH] therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours, in participants with WHO FC III PAH or WHO FC IV PAH at high risk of mortality.
Participants who were eligible for this study presented with symptomatic PAH that was classified as idiopathic, heritable, drug- or toxin-induced, associated with connective tissue disease, or post-shunt correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants on background PAH therapy will be administered placebo by SC injection every 21 days |
|
| Sotatercept | Experimental | Participants on background PAH therapy will be administered sotatercept by SC injection at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Drug | SC injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Confirmed Morbidity or Mortality Event | Morbidity or mortality events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours. All events were adjudicated by a blinded, independent committee of clinical experts. Only adjudication-confirmed lung transplantation and PAH worsening-related hospitalization of ≥24 hours were included in the primary analysis. All deaths that are a first event for a participant were included regardless of adjudication. The time from randomization to the first confirmed morbidity or mortality event, calculated using the non-parametric Kaplan-Meier method, is presented. | Up to approximately 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. The OS for participants, calculated using the non-parametric Kaplan-Meier method, is reported. |
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Inclusion Criteria:
Documented diagnostic right heart catheterization prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
Symptomatic PAH classified as WHO FC III or IV
REVEAL Lite 2.0 risk score of ≥9
Right heart catheterization performed during screening (or within 2 weeks prior to screening, if done at the clinical study site) documenting a minimum PVR of ≥5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤15 mmHg
Clinically stable and on stable doses of maximum tolerated (per investigator's judgment) double or triple background PAH therapies for at least 30 days prior to screening
Females of childbearing potential must:
Male participants must:
Ability to adhere to study visit schedule and understand and comply with all protocol requirements
Ability to understand and provide written informed consent
Exclusion Criteria:
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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 | 85013 | United States | ||
| David Geffen School of Medicine at UCLA ( Site 1068) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167274 | Result | Humbert M, McLaughlin VV, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Preston IR, Souza R, Waxman AB, Moles VM, Savale L, Vizza CD, Rosenkranz S, Shi Y, Miller B, Mackenzie HS, Kim SS, Loureiro MJ, Patel MJ, Koglin J, Cornell AG, Hoeper MM; ZENITH Trial Investigators. Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death. N Engl J Med. 2025 May 29;392(20):1987-2000. doi: 10.1056/NEJMoa2415160. Epub 2025 Mar 31. |
| Label | URL |
|---|---|
| Merck Clinical Trial Information | View source |
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Protocol-specified final analysis of all outcome measures is reported here. Per protocol, participants completing this study may have been eligible to enroll in an open-label, long-term follow-up study (MK-7962-004; NCT04796337).
Of 255 screened participants, 173 were randomized. One participant was randomized in error and did not receive study treatment. This participant was discontinued from the study and no data was collected. As pre-specified in the statistical analysis plan (SAP), this participant was excluded from all study analyses. Therefore, analyses are presented for 172 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotatercept | Participants on background pulmonary arterial hypertension (PAH) therapy were administered sotatercept by subcutaneous (SC) injection at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, every 21 days for up to approximately 26 months. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2024 | Jul 3, 2025 |
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Each eligible participant will be randomized in a 1:1 ratio to 1 of the following 2 treatment arms during a double-blind placebo-controlled treatment period:
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| Placebo | Other | Placebo-matched SC injection |
|
| Up to approximately 31 months |
| Transplant-free Survival | Transplant-free survival was defined as the time from randomization to the first lung transplantation or death due to any cause. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. Transplant-free survival for participants, calculated using the non-parametric Kaplan-Meier method, is reported. | Up to approximately 31 months |
| Percentage of Participants Who Experienced a Mortality Event | Mortality events were defined as death due to any cause throughout the study. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. The percent of participants who experienced a mortality event is reported. | Up to approximately 31 months |
| Change From Baseline in REVEAL Lite 2.0 Risk Score at Week 24 | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: eGFR (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Percentage of Participants Achieving a Low or Intermediate (≤7) REVEAL Lite 2 Risk Score at Week 24 | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: eGFR (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who achieved a low or intermediate REVEAL Lite 2.0 score at Week 24 is reported. | Week 24 |
| Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is secreted by cardiomyocytes in response to ventricular stretch and is an established noninvasive marker of ventricular dysfunction in patients with PAH. Blood samples were collected at baseline and at Week 24 to measure NT-proBNP levels. Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 24 | mPAP is a hemodynamic variable associated with PAH severity and was measured measured at baseline and at Week 24 by right heart catheterization (RHC). Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) | PVR is a hemodynamic variable associated with PAH severity and was measured at baseline and at Week 24 by right heart catheterization (RHC). Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Percentage of Participants Who Improve in WHO FC | The severity of a participant's PAH symptoms was 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", or "Worsened" (Improved = reduction in FC; Worsened = increase in FC; No change = no change in FC). The percentage of participants who had improvement from baseline in WHO FC at the end of the treatment period is reported. | Baseline and up to approximately 31 months |
| Change From Baseline in 6MWD at Week 24 | 6MWD was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Change From Baseline in Cardiac Output (CO) at Week 24 | CO is a prognostic hemodynamic parameter measured at baseline and at Week 24 by RHC. Median change and full ranges are reported based on observed data. | Baseline and Week 24 |
| Change From Baseline in European Quality of Life (EuroQoL)-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Week 24 | EQ-5D-5L is a standardized measure of health status, consisting of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from <0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Higher scores indicated better health and a positive change in score indicated improved overall health. Per SAP, multiple imputation was used to impute missing data at Week 24 for reasons other than death or a non-fatal clinical worsening event. Range was based on the minimum and maximum of median scores across the imputed dataset (100 repetitions). The change from baseline to Week 24 in EQ-5D-5L index score is reported. | Baseline and Week 24 |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Irvine ( Site 1086) | Orange | California | 92868-2994 | United States |
| University of California San Diego Medical Center ( Site 1002) | San Diego | California | 92037 | United States |
| University of California San Francisco ( Site 1019) | San Francisco | California | 94118 | 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 - PPDS ( Site 1045) | Jacksonville | Florida | 32224 | United States |
| AdventHealth Medical Group Advanced Lung Disease ( Site 1058) | Orlando | Florida | 32804 | United States |
| Northside Hospital ( Site 1073) | Atlanta | Georgia | 30342 | United States |
| University Of Iowa Hospitals and Clinics ( Site 1050) | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center ( Site 1020) | Kansas City | Kansas | 66160 | 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 | United States |
| Washington University School of Medicine ( Site 1022) | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center ( Site 1053) | Omaha | Nebraska | 68105 | United States |
| University of New Mexico Health Sciences Center ( Site 1048) | Albuquerque | New Mexico | 87131 | United States |
| University of Rochester Medical Center - PPDS ( Site 1039) | Rochester | New York | 14642-0001 | United States |
| Duke University Medical Center ( Site 1026) | Durham | North Carolina | 27713 | United States |
| University of Cincinnati Medical Center ( Site 1035) | Cincinnati | Ohio | 45267-0558 | United States |
| The Cleveland Clinic Foundation. ( Site 1065) | Cleveland | Ohio | 44103-3736 | United States |
| Medical University of South Carolina - PPDS ( Site 1003) | Charleston | South Carolina | 29425 | United States |
| Statcare Pulmonary Consultants - Knoxville ( Site 1031) | Knoxville | Tennessee | 37909 | United States |
| University Of Texas Southwestern Medical Center ( Site 1038) | Dallas | Texas | 75390 | United States |
| Medical College of Wisconsin - Froedtert Hospital ( Site 1051) | Milwaukee | Wisconsin | 53226 | United States |
| St Vincent's Hospital Sydney ( Site 1102) | Darlinghurst | New South Wales | 2010 | Australia |
| John Hunter Hospital ( Site 1101) | New Lambton Heights | New South Wales | 2305 | Australia |
| Hôpital Erasme ( Site 1402) | Anderlecht | Bruxelles-Capitale, Region de | 1070 | Belgium |
| UZ Leuven Campus Gasthuisberg ( Site 1401) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Peter Lougheed Centre ( Site 2102) | Calgary | Alberta | T1Y 6J4 | Canada |
| Jewish General Hospital ( Site 2103) | Montreal | Quebec | H3T 1E2 | Canada |
| Hôpitaux Universitaires de Strasbourg ( Site 1307) | Strasbourg | Bas-Rhin | 67000 | France |
| Centre Hospitalier Universitaire de Toulouse. ( Site 1315) | Toulouse | Haute-Garonne | 31059 | France |
| CHU de Nancy - Hôpital de Brabois Adultes ( Site 1308) | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHRU Lille ( Site 1306) | Lille | Nord | 59037 | France |
| Hôpital Louis Pradel ( Site 1317) | Bron | Rhone | 69500 | France |
| CHU Bicêtre ( Site 1304) | Le Kremlin-Bicêtre | Val-de-Marne | 94275 | France |
| CHU de Poitiers ( Site 1316) | Poitiers | Vienne | 86021 | France |
| Thoraxklinik-Heidelberg gGmbH ( Site 1509) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Krankenhaus Neuwittelsbach ( Site 1510) | München | Bavaria | 80639 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512) | Giessen | Hesse | 35392 | Germany |
| Medizinische Hochschule Hannover ( Site 1505) | Hanover | Lower Saxony | 30625 | Germany |
| Uniklinik Köln ( Site 1511) | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum des Saarlandes ( Site 1513) | Homburg | Saarland | 66424 | Germany |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501) | Dresden | Saxony | 01307 | Germany |
| Lady Davis Carmel Medical Center ( Site 1705) | Haifa | 34362 | Israel |
| Ospedale S. Giuseppe Multimedica ( Site 2403) | Milan | Lombardy | 20123 | Italy |
| La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402) | Roma | 161 | Italy |
| Instituto Nacional De Cardiologia Dr. Ignacio Chavez ( Site 2503) | Mexico City | Mexico City | 14080 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2504) | Monterrey | Nuevo León | 64460 | Mexico |
| Unidad de Investigación ClÃnica en Medicina, S.C ( Site 2505) | Monterrey | Nuevo León | 64718 | Mexico |
| VU Medisch Centrum ( Site 2601) | Amsterdam | North Holland | 1081 HV | Netherlands |
| Hospital Universitario 12 de Octubre ( Site 1603) | Madrid | 28041 | Spain |
| Royal Papworth Hospital ( Site 1208) | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Royal Brompton Hospital ( Site 1206) | London | London, City of | SW3 6JY | United Kingdom |
| Imperial College Healthcare NHS Trust ( Site 1203) | London | London, City of | W2 1NY | United Kingdom |
| Plain Language Summary | View source |
Participants on background PAH therapy were administered placebo by SC injection every 21 days for up to approximately 26 months. |
| COMPLETED |
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| NOT COMPLETED |
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|
Of the 173 participants randomized in the study, one participant was randomized in error to the placebo arm and then immediately discontinued. This participant did not receive study treatment, and no data was collected. As pre-specified in the SAP, this participant was excluded from all study analyses. 4 participants were randomized in violation of the protocol with a REVEAL score of <9.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sotatercept | Participants on background PAH therapy were administered sotatercept by subcutaneous (SC) injection at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, every 21 days for up to approximately 26 months. |
| BG001 | Placebo | Participants on background PAH therapy were administered placebo by SC injection every 21 days for up to approximately 26 months. |
| 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/Ethnicity, Customized | Count of Participants | Participants |
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| Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Score | PAH participants had REVEAL scores based on 6 variables (sub-score ranges): estimated glomerular filtration rate (eGFR) (0, +1), WHO functional class (FC) (-1, 0, +1, +2), systolic blood pressure (SBP) (0, +1), heart rate (0, +1), 6-minute walk distance (6MWD) (-2, -1, 0, +1), and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) (-2, 0, +2). All sub-scores are added to a base score of +6 and a total REVEAL score of 1 to 14 is obtained (≤5 = low risk; 6,7 = intermediate risk; ≥8 = high risk). 4 participants were randomized in violation of the protocol with a REVEAL score of <9. | Count of Participants | Participants |
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| PAH Subtype | Participants who were eligible for this study presented with symptomatic PAH that was classified as idiopathic, heritable, drug- or toxin-induced, associated with connective tissue disease, or post-shunt correction. | 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 | |||||||||||||||||||||||
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| Primary | Time to First Confirmed Morbidity or Mortality Event | Morbidity or mortality events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours. All events were adjudicated by a blinded, independent committee of clinical experts. Only adjudication-confirmed lung transplantation and PAH worsening-related hospitalization of ≥24 hours were included in the primary analysis. All deaths that are a first event for a participant were included regardless of adjudication. The time from randomization to the first confirmed morbidity or mortality event, calculated using the non-parametric Kaplan-Meier method, is presented. | All randomized participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 31 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. The OS for participants, calculated using the non-parametric Kaplan-Meier method, is reported. | All randomized participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 31 months |
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| Secondary | Transplant-free Survival | Transplant-free survival was defined as the time from randomization to the first lung transplantation or death due to any cause. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. Transplant-free survival for participants, calculated using the non-parametric Kaplan-Meier method, is reported. | All randomized participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 31 months |
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| Secondary | Percentage of Participants Who Experienced a Mortality Event | Mortality events were defined as death due to any cause throughout the study. As pre-specified in the SAP, all deaths up to data cutoff, including among participants who completed or discontinued the study, were included except for those that occurred after enrollment in the long-term follow-up study (MK-7962-004) or after lung transplantation. The percent of participants who experienced a mortality event is reported. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of Participants | Up to approximately 31 months |
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| Secondary | Change From Baseline in REVEAL Lite 2.0 Risk Score at Week 24 | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: eGFR (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had REVEAL Lite 2.0 Risk Score available at both baseline and Week 24. | Posted | Median | Full Range | Scores on a scale | Baseline and Week 24 |
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| Secondary | Percentage of Participants Achieving a Low or Intermediate (≤7) REVEAL Lite 2 Risk Score at Week 24 | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: eGFR (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who achieved a low or intermediate REVEAL Lite 2.0 score at Week 24 is reported. | All randomized participants who received at least one dose of study treatment, who were randomized more than 24 weeks prior to the data cutoff, and who had a REVEAL Lite 2.0 risk score >7 at baseline. | Posted | Number | Percentage of Participants | Week 24 |
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| Secondary | Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is secreted by cardiomyocytes in response to ventricular stretch and is an established noninvasive marker of ventricular dysfunction in patients with PAH. Blood samples were collected at baseline and at Week 24 to measure NT-proBNP levels. Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had NT-proBNP levels available at both baseline and Week 24. | Posted | Median | Full Range | pg/mL | Baseline and Week 24 |
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| Secondary | Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 24 | mPAP is a hemodynamic variable associated with PAH severity and was measured measured at baseline and at Week 24 by right heart catheterization (RHC). Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had mPAP available at both baseline and Week 24. | Posted | Median | Full Range | mmHg | Baseline and Week 24 |
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| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) | PVR is a hemodynamic variable associated with PAH severity and was measured at baseline and at Week 24 by right heart catheterization (RHC). Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had PVR available at both baseline and Week 24. | Posted | Median | Full Range | Dynes*sec/cm^5 | Baseline and Week 24 |
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| Secondary | Percentage of Participants Who Improve in WHO FC | The severity of a participant's PAH symptoms was 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", or "Worsened" (Improved = reduction in FC; Worsened = increase in FC; No change = no change in FC). The percentage of participants who had improvement from baseline in WHO FC at the end of the treatment period is reported. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of Participants | Baseline and up to approximately 31 months |
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| Secondary | Change From Baseline in 6MWD at Week 24 | 6MWD was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had 6MWD available at both baseline and Week 24. | Posted | Median | Full Range | Meters | Baseline and Week 24 |
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| Secondary | Change From Baseline in Cardiac Output (CO) at Week 24 | CO is a prognostic hemodynamic parameter measured at baseline and at Week 24 by RHC. Median change and full ranges are reported based on observed data. | All randomized participants who received at least one dose of study treatment and who had CO available at both baseline and Week 24. | Posted | Median | Full Range | Liters/minute | Baseline and Week 24 |
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| Secondary | Change From Baseline in European Quality of Life (EuroQoL)-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Week 24 | EQ-5D-5L is a standardized measure of health status, consisting of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from <0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Higher scores indicated better health and a positive change in score indicated improved overall health. Per SAP, multiple imputation was used to impute missing data at Week 24 for reasons other than death or a non-fatal clinical worsening event. Range was based on the minimum and maximum of median scores across the imputed dataset (100 repetitions). The change from baseline to Week 24 in EQ-5D-5L index score is reported. | All randomized participants who received at least one dose of study treatment, who were randomized more than 24 weeks prior to the data cutoff, and who had data available from at least one baseline and post-baseline PRO assessment. | Posted | Median | Full Range | Scores on a Scale | Baseline and Week 24 |
|
Up to approximately 31 months
All-cause mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 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 | Participants on background pulmonary arterial hypertension (PAH) therapy were administered sotatercept by subcutaneous (SC) injection at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, every 21 days for up to approximately 26 months. | 13 | 86 | 52 | 86 | 82 | 86 |
| EG001 | Placebo | Participants on background PAH therapy were administered placebo by SC injection every 21 days for up to approximately 26 months. | 20 | 86 | 64 | 86 | 77 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vascular device occlusion | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonal skin infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal empyema | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac output decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Therapy change | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Artery dissection | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Reperfusion injury | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
No publication or disclosure of study results will be permitted except as specified in a separate, written agreement between the Sponsor and the investigator. 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2024 | Jul 3, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542017 | ACE-011 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| West Indian |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 9 to 10 |
|
| ≥11 |
|
| Heritable PAH |
|
| Drug or toxin-induced PAH |
|
| PAH associated with connective tissue disease |
|
| PAH associated with simple, congenital systemic-to-pulmonary shunts >1 year following shunt repair |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Participants on background PAH therapy were administered placebo by SC injection every 21 days for up to approximately 26 months. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG001 | Placebo | Participants on background PAH therapy were administered placebo by SC injection every 21 days for up to approximately 26 months. |
|
|