search
Back to results

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (HYPERION)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sotatercept
Placebo
Sponsored by
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary, Hypertension, Sotatercept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible participants must meet all of the following criteria to be enrolled in the study:

  1. Age ≥ 18 years

  2. Documented diagnostic right heart catheterization (RHC) within 6 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:

    • Idiopathic PAH
    • Heritable PAH
    • Drug/toxin-induced PAH
    • PAH associated with connective tissue disease
    • PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
  3. Symptomatic PAH classified as WHO FC II or III
  4. REVEAL Lite 2 Risk Score ≥ 6
  5. Diagnosis of PAH within 12 months of screening and on stable doses of a double combination of background PAH therapies and diuretics for at least 90 days prior to screening
  6. Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)

  7. Females of childbearing potential must meet the following criteria:

    • Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
    • If sexually active with a male partner, have used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product AND agreed to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions) and for 16 weeks (112 days) after discontinuation of study treatment
    • Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment

  8. Male participants must meet the following criteria:

    • Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
    • Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
  9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
  10. Ability to understand and provide written informed consent

Exclusion Criteria:

Participants will be excluded from the study if any of the following criteria are met:

  1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
  2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis
  3. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
  4. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg during the Screening Visit after a period of rest
  5. Baseline systolic BP < 90 mmHg at screening
  6. Pregnant or breastfeeding women

  7. Any of the following clinical laboratory values at the Screening Visit:

    • Estimated glomerular filtration rate < 30 mL/min/m2 (as defined by MDRD equation)
    • Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels > 3 × ULN
    • Platelet count < 50,000/mm3 (< 50.0 × 109 /L)
  8. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent
  9. Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
  10. History of pneumonectomy
  11. Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
  12. Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
  13. 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)
  14. Untreated more than mild obstructive sleep apnea
  15. History of known pericardial constriction
  16. History of restrictive or congestive cardiomyopathy
  17. History of atrial septostomy within 180 days prior to the Screening Visit
  18. 18. Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period
  19. Personal or family history of long QT syndrome or sudden cardiac death
  20. Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
  21. Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
  22. Cerebrovascular accident within 3 months prior to the Screening Visit
  23. Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
  24. Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
  25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit

Sites / Locations

  • Arizona Pulmonary Specialists ( Site 1010)Recruiting
  • University of Arizona ( Site 1006)Recruiting
  • University of California San Diego ( Site 1002)Recruiting
  • David Geffen School of Medicine at UCLA ( Site 1068)Recruiting
  • University of California Irvine ( Site 1086)Recruiting
  • Jeffrey S.Sager MD Medical Corporation ( Site 1060)Recruiting
  • University of California Davis Medical Center ( Site 1064)Recruiting
  • University of Colorado Hospital ( Site 1013)Recruiting
  • AdventHealth Medical Group Advanced Lung Disease ( Site 1058)Recruiting
  • University of Iowa Hospital and Clinics ( Site 1050)Recruiting
  • Johns Hopkins Hospital ( Site 1036)Recruiting
  • Tufts Medical Center ( Site 1012)Recruiting
  • Brigham & Women's Hospital ( Site 1014)Recruiting
  • University of Michigan ( Site 1011)Recruiting
  • University of Kansas Medical Center ( Site 1020)Recruiting
  • Washington University School of Medicine ( Site 1022)Recruiting
  • University of New Mexico, Health Sciences Center ( Site 1048)Recruiting
  • NYU Langone Health ( Site 1052)Recruiting
  • University of North Carolina at Chapel Hill ( Site 1042)Recruiting
  • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)Recruiting
  • University of Cincinnati Health ( Site 1035)Recruiting
  • The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)Recruiting
  • Nazih Zuhdi Transplantation Institute ( Site 1084)Recruiting
  • Oregon Health & Science University ( Site 1054)Recruiting
  • Medical University of South Carolina ( Site 1003)Recruiting
  • University of Texas Southwestern Medical Center ( Site 1038)Recruiting
  • University of Utah ( Site 1049)Recruiting
  • Cardiologia Palermo ( Site 1911)Recruiting
  • Centro Medico Dra De Salvo ( Site 1904)Recruiting
  • Hospital Universitario Austral ( Site 1901)Recruiting
  • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)Recruiting
  • Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)Recruiting
  • Instituto Médico DAMIC ( Site 1909)Recruiting
  • Instituto Medico Rio Cuarto ( Site 1907)Recruiting
  • Hospital Provincial del Centenario ( Site 1912)Recruiting
  • Instituto Cardiovascular de Rosario ( Site 1906)Recruiting
  • Sanatorio Parque ( Site 1905)Recruiting
  • Sanatorio Allende ( Site 1908)Recruiting
  • Hospital Provincial Dr. Jose M. Cullen ( Site 1902)Recruiting
  • Royal Prince Alfred Hospital ( Site 1106)Recruiting
  • John Hunter Hospital ( Site 1101)Recruiting
  • Prince Charles Hospital ( Site 1104)Recruiting
  • Princess Alexandra Hospital ( Site 1108)Recruiting
  • Royal Adelaide Hospital ( Site 1109)Recruiting
  • Royal Hobart Hospital ( Site 1107)Recruiting
  • Fiona Stanley Hospital ( Site 1103)Recruiting
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)Recruiting
  • Medizinische Universität Graz ( Site 2003)Recruiting
  • Medizinische Universitat Innsbruck ( Site 2004)Recruiting
  • Medizinische Universitat Wien ( Site 2001)Recruiting
  • Hopital Erasme ( Site 1402)Recruiting
  • UZ Gasthuisberg ( Site 1401)Recruiting
  • Hospital Madre Teresa ( Site 1804)Recruiting
  • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)Recruiting
  • Hospital Sao Paulo ( Site 1806)Recruiting
  • Instituto do Coracao - HCFMUSP ( Site 1803)Recruiting
  • University of Alberta Hospital ( Site 2101)Recruiting
  • St Boniface General Hospital ( Site 2106)Recruiting
  • St. Joseph's Healthcare Hamilton ( Site 2105)Recruiting
  • Sir Mortimer B Davis Jewish General Hospital ( Site 2103)Recruiting
  • Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)Recruiting
  • Fundacion Neumologica Colombiana ( Site 3403)Recruiting
  • Fundacion Valle Del Lili ( Site 3401)Recruiting
  • Centro Medico Imbanaco de Cali S.A ( Site 3404)Recruiting
  • University Hospital Centre Split city ( Site 3901)Recruiting
  • Klinicki Bolnicki Centar Zagreb ( Site 3902)Recruiting
  • Institut Klinicke a Experimentalni Mediciny ( Site 2202)Recruiting
  • Vseobecna fakultni nemocnice v Praze ( Site 2201)Recruiting
  • Rigshospitalet ( Site 3802)Recruiting
  • Aarhus Universitetshospital, Skejby ( Site 3801)Recruiting
  • Hopital Louis Pasteur ( Site 1311)Recruiting
  • Hopital Louis Pradel ( Site 1317)Recruiting
  • Hopitaux Universitaires de Strasbourg ( Site 1307)Recruiting
  • Hopital Cavale Blanche ( Site 1314)Recruiting
  • Hopital de la Cote de Nacre - Caen ( Site 1325)Recruiting
  • Hopital Haut Leveque ( Site 1312)Recruiting
  • CHU de Toulouse - Hopital Larrey ( Site 1315)Recruiting
  • C.H.U. de Tours - Hopital Bretonneau ( Site 1310)Recruiting
  • CHU de Grenoble - Hopital Michallon ( Site 1303)Recruiting
  • Hopital Nord Laennec ( Site 1309)Recruiting
  • Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)Recruiting
  • CHU Angers ( Site 1313)Recruiting
  • C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)Recruiting
  • CHU - Hopital de Bicetre ( Site 1304)Recruiting
  • CHRU LA MILETRIE ( Site 1316)Recruiting
  • Thoraxklinik-Heidelberg gGmbH ( Site 1509)Recruiting
  • Krankenhaus Neuwittelsbach ( Site 1510)Recruiting
  • Universitaetsklinik Regensburg ( Site 1503)Recruiting
  • Medizinische Hochschule Hannover ( Site 1505)Recruiting
  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)Recruiting
  • Uniklinik Köln ( Site 1511)Recruiting
  • Universitatsklinikum des Saarlandes ( Site 1513)Recruiting
  • Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)Recruiting
  • Universitaetsklinikum Carl Gustav Carus ( Site 1501)Recruiting
  • Universitatsklinikum Leipzig ( Site 1508)Recruiting
  • DRK Kliniken Berlin Westend ( Site 1507)Recruiting
  • Onassis Cardiac Surgery Center ( Site 3602)Recruiting
  • Evangelismos General Hospital of Athens ( Site 3605)Recruiting
  • Attikon University General Hospital of Athens ( Site 3604)Recruiting
  • AHEPA University General Hospital of Thessaloniki ( Site 3601)Recruiting
  • Assuta Ashdod Medical Center ( Site 1710)Recruiting
  • Lady Davis Carmel Medical Center ( Site 1705)Recruiting
  • Hadassah Medical Center ( Site 1711)Recruiting
  • Sheba Medical Center ( Site 1701)Recruiting
  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)Recruiting
  • Ospedale S. Giuseppe Multimedica ( Site 2403)Recruiting
  • Azienda Ospedaliera San Gerardo di Monza ( Site 2406)Recruiting
  • Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)Recruiting
  • Azienda Policlinico Umberto I ( Site 2402)Recruiting
  • Gachon University Gil Medical Center ( Site 3103)Recruiting
  • Chonnam National University Hospital ( Site 3105)Recruiting
  • Samsung Medical Center ( Site 3106)Recruiting
  • Seoul National University Hospital ( Site 3102)Recruiting
  • Severance Hospital Yonsei University Health System - PPDS ( Site 3101)Recruiting
  • The Catholic University of Korea St. Mary s Hospital ( Site 3104)Recruiting
  • Radboud University Nijmegen Medical Centre ( Site 2605)Recruiting
  • Maastricht University Medical Center ( Site 2603)Recruiting
  • VU Medisch Centrum ( Site 2601)Recruiting
  • Erasmus MC ( Site 2604)Recruiting
  • Waikato District Health Board ( Site 2702)Recruiting
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)Recruiting
  • Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)Recruiting
  • Hospital Garcia de Orta ( Site 3501)Recruiting
  • Centro Hospitalar E Universitário De Coimbra ( Site 3502)Recruiting
  • Hospital Pulido Valente ( Site 3503)Recruiting
  • Institute for pulmonary diseases of Vojvodina ( Site 2906)Recruiting
  • University Clinical Center Nis ( Site 2904)Recruiting
  • Clinical Center Kragujevac ( Site 2905)Recruiting
  • Clinical Center of Serbia ( Site 2901)Recruiting
  • Hospital Universitario Marques de Valdecilla ( Site 1601)Recruiting
  • Hospital Universitario de Son Espases ( Site 1611)Recruiting
  • Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)Recruiting
  • Hospital Universitari Vall de Hebron ( Site 1605)Recruiting
  • Hospital Universitario 12 de Octubre ( Site 1603)Recruiting
  • Hospital Universitario La Paz ( Site 1610)Recruiting
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)Recruiting
  • Hospital Universitario de Toledo ( Site 1607)Recruiting
  • Skanes Universitetssjukhus Lund ( Site 3203)
  • Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)Recruiting
  • Norrlands Universitetssjukhus ( Site 3205)Recruiting
  • UniversitätsSpital Zürich ( Site 3301)Recruiting
  • Kaohsiung Veterans General Hospital ( Site 3702)Recruiting
  • China Medical University Hospital ( Site 3701)Recruiting
  • National Cheng Kung University Hospital ( Site 3703)Recruiting
  • Papworth Hospital NHS Foundation Trust ( Site 1208)Recruiting
  • Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)Recruiting
  • Golden Jubilee National Hospital ( Site 1204)Recruiting
  • Royal Free London NHS Foundation Trust ( Site 1202)Recruiting
  • Royal Brompton Hospital ( Site 1206)Recruiting
  • Imperial College Healthcare NHS Trust ( Site 1203)Recruiting
  • Freeman Hospital ( Site 1205)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo plus background PAH therapy

Sotatercept plus background PAH therapy

Arm Description

Administered subcutaneously (SC) every 21 days plus background PAH therapy

Administered at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy

Outcomes

Primary Outcome Measures

Time to Clinical Worsening
Time to clinical worsening is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant and deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO functional class from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events will be adjudicated by a blinded, independent committee of clinical experts.

Secondary Outcome Measures

Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal prohormone Btype natriuretic peptide (NT-ProBNP) and World Health Organization (WHO) Functional Class (FC)
Multicomponent improvement endpoint measured by the percentage of participants achieving all of the following at Week 24 relative to baseline: Improvement in 6MWD Improvement or maintenance/achievement of NT-proBNP Improvement in WHO FC or maintenance of WHO FC II
Percentage of Participants who Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score
The REVEAL Lite 2 uses renal insufficiency (by estimated glomerular filtration rate (eGFR)), WHO FC, systolic blood pressure (SBP) and heart rate, 6MWD, and NT-proBNP to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of ≤5, intermediate risk as a score of 6 or 7, and high risk as a score of ≥8 for the survival rates.
Percentage of Participants who Maintain or Achieve a Low Simplified French Risk Score
The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintain or achieve a low risk score at Week 24 versus baseline using the simplified French Risk score calculator will be reported.
Change from Baseline in NT-proBNP Levels
Blood samples will be collected at baseline and at Week 24 to measure NT-proBNP blood concentration.
Percentage of Participants who Improve in WHO FC or Maintain WHO FC II at 24 Weeks from Baseline
The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range 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). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.
Change from Baseline in 6MWD
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Change from baseline in 6MWD at Week 24 will be reported.
Change from Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Change from Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Change from Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported

Full Information

First Posted
March 16, 2021
Last Updated
October 19, 2023
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
search

1. Study Identification

Unique Protocol Identification Number
NCT04811092
Brief Title
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Acronym
HYPERION
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.
Detailed Description
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- or high risk PAH participants. Participants enrolled in the study will have a diagnosis within 6 months of study screening of symptomatic PAH (World Health Organization (WHO) Group 1, classified as functional class (FC) II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin- induced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Pulmonary, Hypertension, Sotatercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
662 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo plus background PAH therapy
Arm Type
Placebo Comparator
Arm Description
Administered subcutaneously (SC) every 21 days plus background PAH therapy
Arm Title
Sotatercept plus background PAH therapy
Arm Type
Experimental
Arm Description
Administered at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy
Intervention Type
Drug
Intervention Name(s)
Sotatercept
Other Intervention Name(s)
MK-7962, ACE-011
Intervention Description
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to Clinical Worsening
Description
Time to clinical worsening is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant and deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO functional class from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events will be adjudicated by a blinded, independent committee of clinical experts.
Time Frame
From time of randomization to the time of first clinical worsening event (Up to approximately 56 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal prohormone Btype natriuretic peptide (NT-ProBNP) and World Health Organization (WHO) Functional Class (FC)
Description
Multicomponent improvement endpoint measured by the percentage of participants achieving all of the following at Week 24 relative to baseline: Improvement in 6MWD Improvement or maintenance/achievement of NT-proBNP Improvement in WHO FC or maintenance of WHO FC II
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score
Description
The REVEAL Lite 2 uses renal insufficiency (by estimated glomerular filtration rate (eGFR)), WHO FC, systolic blood pressure (SBP) and heart rate, 6MWD, and NT-proBNP to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of ≤5, intermediate risk as a score of 6 or 7, and high risk as a score of ≥8 for the survival rates.
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Maintain or Achieve a Low Simplified French Risk Score
Description
The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintain or achieve a low risk score at Week 24 versus baseline using the simplified French Risk score calculator will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline in NT-proBNP Levels
Description
Blood samples will be collected at baseline and at Week 24 to measure NT-proBNP blood concentration.
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Improve in WHO FC or Maintain WHO FC II at 24 Weeks from Baseline
Description
The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range 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). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.
Time Frame
Baseline and Week 24
Title
Change from Baseline in 6MWD
Description
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Change from baseline in 6MWD at Week 24 will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®
Description
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
Description
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®
Description
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible participants must meet all of the following criteria to be enrolled in the study: Age ≥ 18 years Documented diagnostic right heart catheterization (RHC) within 6 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH Heritable PAH Drug/toxin-induced PAH PAH associated with connective tissue disease PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair Symptomatic PAH classified as WHO FC II or III REVEAL Lite 2 Risk Score ≥ 6 Diagnosis of PAH within 12 months of screening and on stable doses of a double combination of background PAH therapies and diuretics for at least 90 days prior to screening Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value) Females of childbearing potential must meet the following criteria: Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug If sexually active with a male partner, have used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product AND agreed to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions) and for 16 weeks (112 days) after discontinuation of study treatment Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment Male participants must meet the following criteria: Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment 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: Participants will be excluded from the study if any of the following criteria are met: Diagnosis of pulmonary hypertension (PH) 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, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg during the Screening Visit after a period of rest Baseline systolic BP < 90 mmHg at screening Pregnant or breastfeeding women Any of the following clinical laboratory values at the Screening Visit: Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as defined by MDRD equation) Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels > 3 × ULN Platelet count < 50,000/mm3 (< 50.0 × 109 /L) Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept History of pneumonectomy Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit 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) Untreated more than mild obstructive sleep apnea History of known pericardial constriction History of restrictive or congestive cardiomyopathy History of atrial septostomy within 180 days prior to the Screening Visit Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period Personal or family history of long QT syndrome or sudden cardiac death Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit 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, and vasopressin) within 30 days prior to the Screening Visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Pulmonary Specialists ( Site 1010)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
602-271-0832
Facility Name
University of Arizona ( Site 1006)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
520-626-8000
Facility Name
University of California San Diego ( Site 1002)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
858-657-7076
Facility Name
David Geffen School of Medicine at UCLA ( Site 1068)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-3075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-825-6170
Facility Name
University of California Irvine ( Site 1086)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
949-824-6256
Facility Name
Jeffrey S.Sager MD Medical Corporation ( Site 1060)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105-5311
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
805-898-8840
Facility Name
University of California Davis Medical Center ( Site 1064)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
916-734-2260
Facility Name
University of Colorado Hospital ( Site 1013)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
720-848-2786
Facility Name
AdventHealth Medical Group Advanced Lung Disease ( Site 1058)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-303-3638
Facility Name
University of Iowa Hospital and Clinics ( Site 1050)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-356-2577
Facility Name
Johns Hopkins Hospital ( Site 1036)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-955-1755
Facility Name
Tufts Medical Center ( Site 1012)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-636-2892
Facility Name
Brigham & Women's Hospital ( Site 1014)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-525-9733
Facility Name
University of Michigan ( Site 1011)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
734-232-3741
Facility Name
University of Kansas Medical Center ( Site 1020)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913-588-2314
Facility Name
Washington University School of Medicine ( Site 1022)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-362-1000
Facility Name
University of New Mexico, Health Sciences Center ( Site 1048)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
505-272-1129
Facility Name
NYU Langone Health ( Site 1052)
City
New York
State/Province
New York
ZIP/Postal Code
10016-9196
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-263-9189
Facility Name
University of North Carolina at Chapel Hill ( Site 1042)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
984-974-8236
Facility Name
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
513-585-1777
Facility Name
University of Cincinnati Health ( Site 1035)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0558
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
513-503-5284
Facility Name
The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
734-232-3741
Facility Name
Nazih Zuhdi Transplantation Institute ( Site 1084)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
405-945-4805
Facility Name
Oregon Health & Science University ( Site 1054)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-297-3778
Facility Name
Medical University of South Carolina ( Site 1003)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8900
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-792-3162
Facility Name
University of Texas Southwestern Medical Center ( Site 1038)
City
Dallas
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-645-5989
Facility Name
University of Utah ( Site 1049)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-585-7676
Facility Name
Cardiologia Palermo ( Site 1911)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425BNG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541148339060
Facility Name
Centro Medico Dra De Salvo ( Site 1904)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541147815331
Facility Name
Hospital Universitario Austral ( Site 1901)
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+542304482000
Facility Name
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541135804733
Facility Name
Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)
City
Villa Vatteone
State/Province
Buenos Aires
ZIP/Postal Code
B1853AIK
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541120739884
Facility Name
Instituto Médico DAMIC ( Site 1909)
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
5003DCE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543514888230
Facility Name
Instituto Medico Rio Cuarto ( Site 1907)
City
Rio Cuarto
State/Province
Cordoba
ZIP/Postal Code
X5800AEV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543584679333
Facility Name
Hospital Provincial del Centenario ( Site 1912)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2002
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543414375807
Facility Name
Instituto Cardiovascular de Rosario ( Site 1906)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSR
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(520) 626-8000
Facility Name
Sanatorio Parque ( Site 1905)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543413696444
Facility Name
Sanatorio Allende ( Site 1908)
City
Cordoba
ZIP/Postal Code
X5021FPQ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543514250526
Facility Name
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
City
Santa Fe
ZIP/Postal Code
S3000EOZ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543424528250
Facility Name
Royal Prince Alfred Hospital ( Site 1106)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61295199669
Facility Name
John Hunter Hospital ( Site 1101)
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2308
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61240420133
Facility Name
Prince Charles Hospital ( Site 1104)
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61731394000
Facility Name
Princess Alexandra Hospital ( Site 1108)
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61731763091
Facility Name
Royal Adelaide Hospital ( Site 1109)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61870745244
Facility Name
Royal Hobart Hospital ( Site 1107)
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61361668508
Facility Name
Fiona Stanley Hospital ( Site 1103)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61861511154
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4373276760
Facility Name
Medizinische Universität Graz ( Site 2003)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+433163809618
Facility Name
Medizinische Universitat Innsbruck ( Site 2004)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4351250481413
Facility Name
Medizinische Universitat Wien ( Site 2001)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4314040043910
Facility Name
Hopital Erasme ( Site 1402)
City
Anderlecht
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3225553111
Facility Name
UZ Gasthuisberg ( Site 1401)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3216341245
Facility Name
Hospital Madre Teresa ( Site 1804)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30430-142
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+553133398115
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555132148143
Facility Name
Hospital Sao Paulo ( Site 1806)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04038-031
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551155792581
Facility Name
Instituto do Coracao - HCFMUSP ( Site 1803)
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551126615797
Facility Name
University of Alberta Hospital ( Site 2101)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(780) 407-1586
Facility Name
St Boniface General Hospital ( Site 2106)
City
Winnepeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(204) 235-3581
Facility Name
St. Joseph's Healthcare Hamilton ( Site 2105)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905-522-1155
Facility Name
Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(514) 398-8307
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5744422200
Facility Name
Fundacion Neumologica Colombiana ( Site 3403)
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110131
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5717428914
Facility Name
Fundacion Valle Del Lili ( Site 3401)
City
Santiago De Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5723157974
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 3404)
City
Santiago de Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573138534831
Facility Name
University Hospital Centre Split city ( Site 3901)
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38521556111
Facility Name
Klinicki Bolnicki Centar Zagreb ( Site 3902)
City
Zagreb
State/Province
Zagrebacka Zupanija
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38512385283
Facility Name
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420261363387
Facility Name
Vseobecna fakultni nemocnice v Praze ( Site 2201)
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420224967066
Facility Name
Rigshospitalet ( Site 3802)
City
København Ø
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4535457752
Facility Name
Aarhus Universitetshospital, Skejby ( Site 3801)
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4578450000
Facility Name
Hopital Louis Pasteur ( Site 1311)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33389124000
Facility Name
Hopital Louis Pradel ( Site 1317)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33472681301
Facility Name
Hopitaux Universitaires de Strasbourg ( Site 1307)
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493514585089
Facility Name
Hopital Cavale Blanche ( Site 1314)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33298347600
Facility Name
Hopital de la Cote de Nacre - Caen ( Site 1325)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33231064678
Facility Name
Hopital Haut Leveque ( Site 1312)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33556556424
Facility Name
CHU de Toulouse - Hopital Larrey ( Site 1315)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33567771637
Facility Name
C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33247473714
Facility Name
CHU de Grenoble - Hopital Michallon ( Site 1303)
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33664810986
Facility Name
Hopital Nord Laennec ( Site 1309)
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33240083333
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33477828070
Facility Name
CHU Angers ( Site 1313)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33241354769
Facility Name
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
City
Vandoeuvre Les Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33383153708
Facility Name
CHU - Hopital de Bicetre ( Site 1304)
City
Le Kremlin Bicetre
State/Province
Val-de-Marne
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33145217916
Facility Name
CHRU LA MILETRIE ( Site 1316)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33549443117
Facility Name
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 6221 3960
Facility Name
Krankenhaus Neuwittelsbach ( Site 1510)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80639
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 89 13040
Facility Name
Universitaetsklinik Regensburg ( Site 1503)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+499419444489
Facility Name
Medizinische Hochschule Hannover ( Site 1505)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+495115329184
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+496419945113
Facility Name
Uniklinik Köln ( Site 1511)
City
Koln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+492214785860
Facility Name
Universitatsklinikum des Saarlandes ( Site 1513)
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4968411621328
Facility Name
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493455572622
Facility Name
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493514585089
Facility Name
Universitatsklinikum Leipzig ( Site 1508)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493419712600
Facility Name
DRK Kliniken Berlin Westend ( Site 1507)
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493030350
Facility Name
Onassis Cardiac Surgery Center ( Site 3602)
City
Athens
State/Province
Attiki
ZIP/Postal Code
176 74
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302109493341
Facility Name
Evangelismos General Hospital of Athens ( Site 3605)
City
Athina
State/Province
Attiki
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107201211
Facility Name
Attikon University General Hospital of Athens ( Site 3604)
City
Haidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302105832184
Facility Name
AHEPA University General Hospital of Thessaloniki ( Site 3601)
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302310993261
Facility Name
Assuta Ashdod Medical Center ( Site 1710)
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972532227937
Facility Name
Lady Davis Carmel Medical Center ( Site 1705)
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97248342707
Facility Name
Hadassah Medical Center ( Site 1711)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97226777595
Facility Name
Sheba Medical Center ( Site 1701)
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97235343888
Facility Name
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 040 399 4749
Facility Name
Ospedale S. Giuseppe Multimedica ( Site 2403)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390285991
Facility Name
Azienda Ospedaliera San Gerardo di Monza ( Site 2406)
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390392331
Facility Name
Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390817061111
Facility Name
Azienda Policlinico Umberto I ( Site 2402)
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39064451857
Facility Name
Gachon University Gil Medical Center ( Site 3103)
City
Namdong-Gu
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82324603778
Facility Name
Chonnam National University Hospital ( Site 3105)
City
Gwangju
State/Province
Kyonggi-do
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82622205114
Facility Name
Samsung Medical Center ( Site 3106)
City
Seuol
State/Province
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234103892
Facility Name
Seoul National University Hospital ( Site 3102)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+821091601357
Facility Name
Severance Hospital Yonsei University Health System - PPDS ( Site 3101)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222285220
Facility Name
The Catholic University of Korea St. Mary s Hospital ( Site 3104)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222586007
Facility Name
Radboud University Nijmegen Medical Centre ( Site 2605)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31243616928
Facility Name
Maastricht University Medical Center ( Site 2603)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31433871049
Facility Name
VU Medisch Centrum ( Site 2601)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31204444444
Facility Name
Erasmus MC ( Site 2604)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31107033612
Facility Name
Waikato District Health Board ( Site 2702)
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6478599180
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48126143501
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48227103010
Facility Name
Hospital Garcia de Orta ( Site 3501)
City
Almada
State/Province
Setubal
ZIP/Postal Code
2801-951
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351212940294
Facility Name
Centro Hospitalar E Universitário De Coimbra ( Site 3502)
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351239400400
Facility Name
Hospital Pulido Valente ( Site 3503)
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217548085
Facility Name
Institute for pulmonary diseases of Vojvodina ( Site 2906)
City
Sremska kamenica
State/Province
Juznobacki Okrug
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+381214805225
Facility Name
University Clinical Center Nis ( Site 2904)
City
Nis
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38118333752
Facility Name
Clinical Center Kragujevac ( Site 2905)
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+38134370208
Facility Name
Clinical Center of Serbia ( Site 2901)
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+381112685662
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1601)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34942202583
Facility Name
Hospital Universitario de Son Espases ( Site 1611)
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34871205110
Facility Name
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34911917297
Facility Name
Hospital Universitari Vall de Hebron ( Site 1605)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932742779
Facility Name
Hospital Universitario 12 de Octubre ( Site 1603)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914692313
Facility Name
Hospital Universitario La Paz ( Site 1610)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34917271785
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34656675778
Facility Name
Hospital Universitario de Toledo ( Site 1607)
City
Toledo
ZIP/Postal Code
41007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34600162109
Facility Name
Skanes Universitetssjukhus Lund ( Site 3203)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Completed
Facility Name
Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46186110000
Facility Name
Norrlands Universitetssjukhus ( Site 3205)
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4690785000
Facility Name
UniversitätsSpital Zürich ( Site 3301)
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41442551021
Facility Name
Kaohsiung Veterans General Hospital ( Site 3702)
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88673468097
Facility Name
China Medical University Hospital ( Site 3701)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886422052121
Facility Name
National Cheng Kung University Hospital ( Site 3703)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88663028130
Facility Name
Papworth Hospital NHS Foundation Trust ( Site 1208)
City
Cambrigge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 0AY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441223639672
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)
City
Sheffield
State/Province
Derbyshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441142711900
Facility Name
Golden Jubilee National Hospital ( Site 1204)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441419515000
Facility Name
Royal Free London NHS Foundation Trust ( Site 1202)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442077940500
Facility Name
Royal Brompton Hospital ( Site 1206)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442073518905
Facility Name
Imperial College Healthcare NHS Trust ( Site 1203)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442083834657
Facility Name
Freeman Hospital ( Site 1205)
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441912336161

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

We'll reach out to this number within 24 hrs