Back to resultsA Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA)
Primary Purpose
Pulmonary Arterial Hypertension, PAH
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sotatercept
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Participants must have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early.
- Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.
- Participants must have the ability to understand and provide documented informed consent.
Females of childbearing potential must:
- Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug.
- If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug.
- 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 drug.
Male participants must:
- Agree to use a condom, defined as a male latex condom or non latex 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 drug.
- Participants must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the A011-12 study.
Exclusion Criteria:
- Not enrolled in a PAH parent study at the time of enrollment.
- Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
- Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
- Pregnant or breastfeeding females.
Sites / Locations
- Arizona Pulmonary Specialists ( Site 1010)Recruiting
- Pulmonary Associates, PA ( Site 1008)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
- UC Davis - Medial Center ( Site 1064)Recruiting
- University of California San Francisco ( Site 1019)Recruiting
- Jeffrey S.Sager MD Medical Corporation ( Site 1060)Recruiting
- Harbor UCLA Medical Center ( Site 1028)Recruiting
- University of Colorado Hospital ( Site 1013)Recruiting
- The George Washington University Medical Faculty Associates ( Site 1025)Recruiting
- Mayo Clinic Jacksonville - PPDS ( Site 1045)Recruiting
- AdventHealth Orlando ( Site 1058)Recruiting
- University of South Florida ( Site 1043)Recruiting
- Emory University ( Site 1030)Recruiting
- University of Iowa Hospital and Clinics ( Site 1050)Recruiting
- Norton Pulmonary Specialists ( Site 1066)Recruiting
- Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)Recruiting
- Tufts Medical Center - PPDS ( Site 1012)Recruiting
- Brigham & Women's Hospital ( Site 1014)Recruiting
- University of Michigan ( Site 1011)Recruiting
- University of Minnesota ( Site 1062)Recruiting
- University of Kansas Medical Center ( Site 1020)Recruiting
- Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)Recruiting
- University of Nebraska Medical Center ( Site 1053)Recruiting
- Renown Regional Medical Center ( Site 1055)Recruiting
- University of New Mexico Health Sciences Center ( Site 1048)Recruiting
- New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)Recruiting
- University of Rochester Medical Center - PPDS ( Site 1039)Recruiting
- The University of North Carolina at Chapel Hill ( Site 1042)Recruiting
- Duke University Medical Center ( Site 1026)Recruiting
- The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)Recruiting
- University of Cincinnati Medical Center ( Site 1035)Recruiting
- The Ohio State University Wexner Medical Center ( Site 1032)Recruiting
- Cleveland Clinic Foundation ( Site 1065)Recruiting
- Integris Health, Inc. ( Site 1084)Recruiting
- The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)Recruiting
- UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)Recruiting
- Rhode Island Hospital ( Site 1033)Recruiting
- Medical University of South Carolina - PPDS ( Site 1003)Recruiting
- Statcare Pulmonary Consultants - Knoxville ( Site 1031)Recruiting
- University of Texas Southwestern Medical Center ( Site 1038)Recruiting
- CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)Recruiting
- Houston Methodist Hospital ( Site 1009)Recruiting
- University of Washington Medical Center ( Site 1067)Recruiting
- Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)Recruiting
- Cardiologia Palermo ( Site 1911)Recruiting
- Instituto de Investigaciones Clinicas Quilmes ( Site 1903)Recruiting
- Centro Medico Dra De Salvo ( Site 1904)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
- Centro Oncologico de Rosario ( Site 1905)Recruiting
- Hospital Universitario Austral ( Site 1901)Recruiting
- Sanatorio Allende ( Site 1908)Recruiting
- Hospital Dr. Jose Maria Cullen ( Site 1902)Recruiting
- Royal Prince Alfred Hospital ( Site 1106)Recruiting
- Saint Vincents Hospital Sydney ( Site 1102)Recruiting
- John Hunter Hospital ( Site 1101)Recruiting
- The Prince Charles Hospital ( Site 1104)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
- Erasme Hospital ( Site 1402)Recruiting
- UZ Leuven - Campus Gasthuisberg ( Site 1401)Recruiting
- Hospital Madre Teresa ( Site 1804)Recruiting
- Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)Recruiting
- Hospital São Lucas da PUCRS ( Site 1801)Recruiting
- Hospital Dia do Pulmao ( Site 1802)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
- Klinički Bolnički Centar Split ( Site 3901)Recruiting
- Klinicki Bolnicki Centar Zagreb ( Site 3902)Recruiting
- Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)Recruiting
- Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)Recruiting
- Rigshospitalet ( Site 3802)Recruiting
- Aarhus Universitetshospital, Skejby ( Site 3801)Recruiting
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)Recruiting
- Hopital Civil - CHU Strasbourg ( Site 1307)Recruiting
- Hopital cote de Nacre ( Site 1325)Recruiting
- Hopital Cavale Blanche ( Site 1314)Recruiting
- Groupe Hospitalier Sud ( Site 1312)Recruiting
- CHU de Toulouse - Hopital Larrey ( Site 1315)Recruiting
- Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)Recruiting
- C.H.U. de Tours - Hopital Bretonneau ( Site 1310)Recruiting
- C.H.U de Grenoble - Hopital Albert 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
- CHRU Lille ( Site 1306)Recruiting
- Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)Recruiting
- CHU - Hopital de Bicetre ( Site 1304)Recruiting
- CHU de la Miletrie Poitiers ( Site 1316)Recruiting
- Thoraxklinik-Heidelberg gGmbH ( Site 1509)Recruiting
- Krankenhaus Neuwittelsbach ( Site 1510)Recruiting
- Universitaetsklinik Regensburg ( Site 1503)Recruiting
- Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)Recruiting
- Medizinische Hochschule Hannover ( Site 1505)Recruiting
- Universitätsklinik Köln ( Site 1511)Recruiting
- Universataet des Saarlandes ( Site 1513)Recruiting
- Universitätsklinikum Halle ( Site 1502)Recruiting
- Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)Recruiting
- Universitatsklinikum Leipzig ( Site 1508)Recruiting
- DRK Kliniken Berlin Westend ( Site 1507)Recruiting
- Attikon University General Hospital of Athens ( Site 3604)Recruiting
- Onassis Cardiac Surgery Center ( Site 3602)Recruiting
- Evangelismos General Hospital of Athens ( Site 3605)Recruiting
- AHEPA University General Hospital of Thessaloniki ( Site 3601)Recruiting
- Assuta Ashdod Medical Center ( Site 1710)Recruiting
- Barzilai Medical Center ( Site 1708)Recruiting
- Lady Davis Carmel Medical Center ( Site 1705)Recruiting
- Hadassah Medical Center ( Site 1711)Recruiting
- Meir Medical Center ( Site 1707)Recruiting
- Rabin Medical Center ( Site 1703)Recruiting
- Sheba MC ( Site 1701)Recruiting
- Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)Recruiting
- Ospedale S. Giuseppe Multimedica ( Site 2403)Recruiting
- Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)Recruiting
- Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)Recruiting
- Universita "La Sapienza" Policlinico Umberto I ( Site 2402)Recruiting
- Chonnam National University Hospital ( Site 3105)Recruiting
- Gachon University Gil Medical Center ( Site 3103)Recruiting
- Seoul National University Hospital ( Site 3102)Recruiting
- Samsung Medical Center ( Site 3106)Recruiting
- The Catholic University Seoul St. Mary's Hospital ( Site 3104)Recruiting
- Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)Recruiting
- Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)Recruiting
- Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)Recruiting
- Hospital Angeles Lomas ( Site 2501)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
- Greenlane Clinical Centre ( Site 2703)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
- Centro Hospitalar Lisboa Norte E.P.E. - 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
- Institute of Cardiovascular Diseases Dedinje ( Site 2903)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 d'Hebron ( Site 1605)Recruiting
- Hospital Clinic de Barcelona ( Site 1602)Recruiting
- Hospital Universitario Ramon y Cajal ( Site 1609)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)Recruiting
- Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)Recruiting
- Norrlands Universitetssjukhus ( Site 3205)Recruiting
- Sahlgrenska Universitetssjukhuset ( Site 3201)Recruiting
- Universitaetsspital Zurich ( 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
- Royal Papworth Hospital ( Site 1208)Recruiting
- Royal Brompton Hospital ( Site 1206)Recruiting
- Golden Jubilee National Hospital ( Site 1204)Recruiting
- Royal Free London NHS Foundation Trust ( Site 1202)Recruiting
- Imperial College Healthcare NHS Trust ( Site 1203)Recruiting
- Royal Hallamshire Hospital ( Site 1207)Recruiting
- The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sotatercept Treatment
Arm Description
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Outcomes
Primary Outcome Measures
Number of Participants Who Experience an Adverse Event (AE)
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP, sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH)
Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months.
Change From Baseline in Body Weight
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Change From Baseline in Blood Pressure
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Change From Baseline in Electrocardiogram (ECG)
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite
Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months.
Secondary Outcome Measures
Change From Baseline in 6-Minute Walk Distance (6MWD)
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported.
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported.
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC)
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported.
Change From Baseline in Pulmonary Vascular Resistance (PVR)
PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported.
Overall Survival (OS)
Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death.
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported.
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported.
Full Information
NCT ID
NCT04796337
First Posted
February 22, 2021
Last Updated
October 19, 2023
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
1. Study Identification
Unique Protocol Identification Number
NCT04796337
Brief Title
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
Acronym
SOTERIA
Official Title
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
November 30, 2027 (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
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.
The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.
Detailed Description
Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, PAH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sotatercept Treatment
Arm Type
Experimental
Arm Description
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Intervention Type
Biological
Intervention Name(s)
Sotatercept
Other Intervention Name(s)
ACE-011, MK-7962
Intervention Description
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
Primary Outcome Measure Information:
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported.
Time Frame
Up to approximately 50 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 50 months
Title
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Description
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Time Frame
Up to approximately 50 months
Title
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Description
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Time Frame
Up to approximately 50 months
Title
Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Description
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP, sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Time Frame
Up to approximately 50 months
Title
Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH)
Description
Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months.
Time Frame
Up to approximately 50 months
Title
Change From Baseline in Body Weight
Description
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in Blood Pressure
Description
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in Electrocardiogram (ECG)
Description
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
Time Frame
Baseline and up to approximately 48 months
Title
Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite
Description
Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months.
Time Frame
Up to approximately 48 months
Secondary Outcome Measure Information:
Title
Change From Baseline in 6-Minute Walk Distance (6MWD)
Description
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
Description
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC)
Description
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Description
PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported.
Time Frame
Baseline and up to approximately 48 months
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death.
Time Frame
Up to approximately 78 months
Title
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
Description
The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported.
Time Frame
Baseline and up to approximately 48 months
Title
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
Description
The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported.
Time Frame
Baseline and up to approximately 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Females of childbearing potential must:
Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
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 drug
Male participants must:
Agree to use a condom, defined as a male latex condom or non latex 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 drug
Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study
Exclusion Criteria:
Did not participate in a sotatercept PAH parent trial
Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
Pregnant or breastfeeding females
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
85012-2369
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
602-271-0832
Facility Name
Pulmonary Associates, PA ( Site 1008)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
602-258-4951
Facility Name
University of Arizona ( Site 1006)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
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
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-222-2467
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
UC Davis - Medial Center ( Site 1064)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-704-4000
Facility Name
University of California San Francisco ( Site 1019)
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
415-353-1798
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
805-845-1500
Facility Name
Harbor UCLA Medical Center ( Site 1028)
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-222-3560
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
The George Washington University Medical Faculty Associates ( Site 1025)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-741-3624
Facility Name
Mayo Clinic Jacksonville - PPDS ( Site 1045)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-953-2232
Facility Name
AdventHealth Orlando ( Site 1058)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-303-7556
Facility Name
University of South Florida ( Site 1043)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-259-0826
Facility Name
Emory University ( Site 1030)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-712-1370
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
Norton Pulmonary Specialists ( Site 1066)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-629-3102
Facility Name
Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-955-6337
Facility Name
Tufts Medical Center - PPDS ( Site 1012)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1526
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
617-525-1267
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 Minnesota ( Site 1062)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
612-827-1131
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
Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108-1495
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-454-8766
Facility Name
University of Nebraska Medical Center ( Site 1053)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
402-559-7182
Facility Name
Renown Regional Medical Center ( Site 1055)
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502-1262
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
775-982-2400
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
New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-305-4436
Facility Name
University of Rochester Medical Center - PPDS ( Site 1039)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
585-275-7434
Facility Name
The 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
Duke University Medical Center ( Site 1026)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
919-668-2642
Facility Name
The 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 Medical Center ( Site 1035)
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
513-558-3975
Facility Name
The Ohio State University Wexner Medical Center ( Site 1032)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
614-688-6687
Facility Name
Cleveland Clinic Foundation ( Site 1065)
City
Twinsburg
State/Province
Ohio
ZIP/Postal Code
44087
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-444-6814
Facility Name
Integris Health, Inc. ( Site 1084)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4492
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
405-945-4805
Facility Name
The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-297-3778
Facility Name
UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-623-4147
Facility Name
Rhode Island Hospital ( Site 1033)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
401-444-0369
Facility Name
Medical University of South Carolina - PPDS ( Site 1003)
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464-3771
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-792-3162
Facility Name
Statcare Pulmonary Consultants - Knoxville ( Site 1031)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
941-924-9800
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
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-355-1000
Facility Name
Houston Methodist Hospital ( Site 1009)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-790-3333
Facility Name
University of Washington Medical Center ( Site 1067)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-598-4477
Facility Name
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
414-805-6444
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
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
+541142531337
Facility Name
Centro Medico Dra De Salvo ( Site 1904)
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
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
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
+54 351 4888230
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
+543414203040
Facility Name
Centro Oncologico de Rosario ( 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
+543414268409
Facility Name
Hospital Universitario Austral ( Site 1901)
City
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491160149487
Facility Name
Sanatorio Allende ( Site 1908)
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543514250526
Facility Name
Hospital Dr. Jose Maria 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
Saint Vincents Hospital Sydney ( Site 1102)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61283823785
Facility Name
John Hunter Hospital ( Site 1101)
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61249214095
Facility Name
The Prince Charles Hospital ( Site 1104)
City
Brisbane
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
+61738769033
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
+61361668308
Facility Name
Fiona Stanley Hospital ( Site 1103)
City
Perth
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
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4373276764916
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
Erasme Hospital ( Site 1402)
City
Bruxelles
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 Leuven - Campus 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 Misericórdia de Porto Alegre ( Site 1805)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-074
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555132148143
Facility Name
Hospital São Lucas da PUCRS ( Site 1801)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555133205010
Facility Name
Hospital Dia do Pulmao ( Site 1802)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+554730377099
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
7804071586
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
2042338563
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
9055221155
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
5143407531
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
+573137963442
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
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
+573155006300
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
Klinički Bolnički Centar Split ( 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
+385 021556129
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
Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( 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
Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)
City
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
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
Centre Hospitalier Universitaire de Nice - Hopital 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
+33492038570
Facility Name
Hopital Civil - CHU 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
+33369550345
Facility Name
Hopital cote de Nacre ( 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
+33231064677
Facility Name
Hopital Cavale Blanche ( Site 1314)
City
Brest
State/Province
Finistere
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
Groupe Hospitalier Sud ( Site 1312)
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33557656439
Facility Name
CHU de Toulouse - Hopital Larrey ( Site 1315)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33567771793
Facility Name
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33467335937
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
C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
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
+33240165235
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
+33383154405
Facility Name
CHRU Lille ( Site 1306)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33320446011
Facility Name
Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
City
Bron
State/Province
Rhone-Alpes
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33472681301
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
+33145212121
Facility Name
CHU de la Miletrie Poitiers ( 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
+33549444689
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
+4962213968053
Facility Name
Krankenhaus Neuwittelsbach ( Site 1510)
City
München
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
+498913042205
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
Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
City
Gießen
State/Province
Hessen
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
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
Universitätsklinik Köln ( Site 1511)
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+492214785860
Facility Name
Universataet des Saarlandes ( Site 1513)
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4968411621328
Facility Name
Universitätsklinikum Halle ( 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 der TU Dresden ( 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
+493419725052
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
Attikon University General Hospital of Athens ( Site 3604)
City
Athens
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
+306945468736
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
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
+972507777618
Facility Name
Barzilai Medical Center ( Site 1708)
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97286712931
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
Meir Medical Center ( Site 1707)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97297472555
Facility Name
Rabin Medical Center ( Site 1703)
City
Petach Tikvah
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97239231437
Facility Name
Sheba MC ( Site 1701)
City
Ramat Gan
ZIP/Postal Code
5265601
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 1111
Facility Name
Ospedale S. Giuseppe Multimedica ( Site 2403)
City
Milano
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
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
City
Monza
State/Province
Lombardia
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 dei Colli 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
Universita "La Sapienza" 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
+390649979051
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
Gachon University Gil Medical Center ( Site 3103)
City
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
+82324603663
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
Samsung Medical Center ( Site 3106)
City
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
The Catholic University Seoul 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
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528888888888
Facility Name
Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528183467800
Facility Name
Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
City
Sertoma
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528181430795
Facility Name
Hospital Angeles Lomas ( Site 2501)
City
Huixquilucan
ZIP/Postal Code
52763
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+525552470671
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 GJ
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
3240
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6478599180
Facility Name
Greenlane Clinical Centre ( Site 2703)
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6496389909
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
Centro Hospitalar Lisboa Norte E.P.E. - 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
+381214805100
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
Institute of Cardiovascular Diseases Dedinje ( Site 2903)
City
Beograd
ZIP/Postal Code
11040
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+381113601701
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
+34942202569
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
+34911917418
Facility Name
Hospital Universitari Vall d'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 Clinic de Barcelona ( Site 1602)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932275786
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1609)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913368000
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+464617141
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
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4690785000
Facility Name
Sahlgrenska Universitetssjukhuset ( Site 3201)
City
Goteburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46313422929
Facility Name
Universitaetsspital Zurich ( 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
813
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
Royal Papworth Hospital ( Site 1208)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441480830541
Facility Name
Royal Brompton Hospital ( Site 1206)
City
London
State/Province
England
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
Golden Jubilee National Hospital ( Site 1204)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G81 4HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441419515497
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
Imperial College Healthcare NHS Trust ( Site 1203)
City
London
State/Province
London, City Of
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441419515497
Facility Name
Royal Hallamshire Hospital ( Site 1207)
City
Sheffield
State/Province
North Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441142712566
Facility Name
The Newcastle Upon Tyne NHS Foundation Trust ( 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
+441912137489
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
http://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information
Learn more about this trial
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
We'll reach out to this number within 24 hrs