Clinical trial NCT04796337: A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
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 (MK-7962-004)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
PAH
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 this study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.

Participants enrolled in this study may be eligible to participate in MK-7962-038 (NCT number pending), an open-label LTFU study to evaluate the effects of sotatercept when added to background PAH therapy.

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, except for the MK-7962-038 study

Exclusion Criteria:

* Did not participate in a sotatercept PAH parent study
* 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 50 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 50 months
measure: Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
timeFrame: Up to approximately 50 months
measure: Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
timeFrame: Up to approximately 50 months
measure: Laboratory parameters (Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
timeFrame: Up to approximately 50 months
measure: Change From Baseline in Body Weight
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in Electrocardiogram (ECG)
timeFrame: Baseline and up to approximately 48 months
Secondary outcomes:
measure: Change From Baseline in 6-Minute Walk Distance (6MWD)
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC)
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in Pulmonary Vascular Resistance (PVR)
timeFrame: Baseline and up to approximately 48 months
measure: Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
timeFrame: Baseline and up to approximately 48 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA ( Site 1008)
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists ( Site 1010)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona ( Site 1006)
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego ( Site 1002)
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA ( Site 1068)
state: California
city: Orange
country: United States
facility: University of California Irvine ( Site 1086)
state: California
city: Sacramento
country: United States
facility: UC Davis - Medial Center ( Site 1064)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco ( Site 1019)
state: California
city: Santa Barbara
country: United States
facility: Jeffrey S.Sager MD Medical Corporation ( Site 1060)
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center ( Site 1028)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital ( Site 1013)
state: Colorado
city: Washington
country: United States
facility: The George Washington University Medical Faculty Associates ( Site 1025)
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville - PPDS ( Site 1045)
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando ( Site 1058)
state: Florida
city: Tampa
country: United States
facility: University of South Florida ( Site 1043)
state: Florida
city: Atlanta
country: United States
facility: Emory University ( Site 1030)
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 1050)
state: Iowa
city: Louisville
country: United States
facility: Norton Pulmonary Specialists ( Site 1066)
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center - PPDS ( Site 1012)
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital ( Site 1014)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 1011)
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota ( Site 1062)
state: Minnesota
city: Kansas City
country: United States
facility: University of Kansas Medical Center ( Site 1020)
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center ( Site 1053)
state: Nebraska
city: Reno
country: United States
facility: Renown Regional Medical Center ( Site 1055)
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center ( Site 1048)
state: New Mexico
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center - PPDS ( Site 1039)
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill ( Site 1042)
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center ( Site 1026)
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 1035)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation ( Site 1065)
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center ( Site 1032)
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Health, Inc. ( Site 1084)
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital ( Site 1033)
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Medical University of South Carolina - PPDS ( Site 1003)
state: South Carolina
city: Knoxville
country: United States
facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 1027)
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center ( Site 1038)
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital ( Site 1009)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - PPDS ( Site 1049)
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center ( Site 1067)
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Cardiologia Palermo ( Site 1911)
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra De Salvo ( Site 1904)
state: Caba
city: Córdoba
country: Argentina
facility: Instituto Médico DAMIC ( Site 1909)
state: Cordoba
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto ( Site 1907)
state: Cordoba
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 1912)
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario ( Site 1906)
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncologico de Rosario ( Site 1905)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral ( Site 1901)
city: Cordoba
country: Argentina
facility: Sanatorio Allende ( Site 1908)
city: Santa Fe
country: Argentina
facility: Hospital Dr. Jose Maria Cullen ( Site 1902)
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital ( Site 1106)
state: New South Wales
city: Darlinghurst
country: Australia
facility: Saint Vincents Hospital Sydney ( Site 1102)
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital ( Site 1101)
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital ( Site 1104)
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital ( Site 1108)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 1109)
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital ( Site 1107)
state: Tasmania
city: Perth
country: Australia
facility: Fiona Stanley Hospital ( Site 1103)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz ( Site 2003)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck ( Site 2004)
state: Tirol
city: Wien
country: Austria
facility: Medizinische Universitat Wien ( Site 2001)
city: Bruxelles
country: Belgium
facility: Erasme Hospital ( Site 1402)
state: Bruxelles-Capitale, Region De
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg ( Site 1401)
state: Vlaams-Brabant
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa ( Site 1804)
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS ( Site 1801)
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmao ( Site 1802)
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Hospital Sao Paulo ( Site 1806)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao - HCFMUSP ( Site 1803)
city: Calgary
country: Canada
facility: Peter Lougheed Centre ( Site 2102)
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital ( Site 2101)
state: Alberta
city: Winnepeg
country: Canada
facility: St Boniface General Hospital ( Site 2106)
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton ( Site 2105)
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
state: Quebec
city: Medellin
country: Colombia
facility: Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
state: Antioquia
city: Bogota
country: Colombia
facility: Fundacion Neumologica Colombiana ( Site 3403)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 3401)
state: Valle Del Cauca
city: Santiago de Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 3404)
state: Valle Del Cauca
city: Split
country: Croatia
facility: Klinički Bolnički Centar Split ( Site 3901)
state: Splitsko-dalmatinska Zupanija
city: Zagreb
country: Croatia
facility: Klinicki Bolnicki Centar Zagreb ( Site 3902)
state: Zagrebacka Zupanija
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)
city: København Ø
country: Denmark
facility: Rigshospitalet ( Site 3802)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby ( Site 3801)
state: Midtjylland
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: Hopital Civil - CHU Strasbourg ( Site 1307)
state: Bas-Rhin
city: Caen
country: France
facility: CHU Caen Normandie ( Site 1325)
state: Calvados
city: Brest
country: France
facility: Hopital Cavale Blanche ( Site 1314)
state: Finistere
city: Pessac
country: France
facility: Groupe Hospitalier Sud ( Site 1312)
state: Gironde
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey ( Site 1315)
state: Haute-Garonne
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
state: Herault
city: Tours
country: France
facility: C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
state: Indre-et-Loire
city: La Tronche
country: France
facility: C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
state: Isere
city: Nantes
country: France
facility: Hopital Nord Laennec ( Site 1309)
state: Loire-Atlantique
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
state: Loire
city: Angers
country: France
facility: CHU Angers ( Site 1313)
state: Maine-et-Loire
city: Vandoeuvre Les Nancy
country: France
facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille ( Site 1306)
state: Nord
city: Bron
country: France
facility: Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
state: Rhone-Alpes
city: Le Kremlin Bicetre
country: France
facility: CHU - Hopital de Bicetre ( Site 1304)
state: Val-de-Marne
city: Poitiers
country: France
facility: CHU de la Miletrie Poitiers ( Site 1316)
state: Vienne
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)
state: Baden-Wurttemberg
city: München
country: Germany
facility: Krankenhaus Neuwittelsbach ( Site 1510)
state: Bayern
city: Regensburg
country: Germany
facility: Universitaetsklinik Regensburg ( Site 1503)
state: Bayern
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 1505)
state: Niedersachsen
city: Cologne
country: Germany
facility: Universitätsklinik Köln ( Site 1511)
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universataet des Saarlandes ( Site 1513)
state: Saarland
city: Halle
country: Germany
facility: Universitätsklinikum Halle ( Site 1502)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)
state: Sachsen
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig ( Site 1508)
state: Sachsen
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend ( Site 1507)
city: Athens
country: Greece
facility: Attikon University General Hospital of Athens ( Site 3604)
state: Attiki
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center ( Site 3602)
state: Attiki
city: Athina
country: Greece
facility: Evangelismos General Hospital of Athens ( Site 3605)
state: Attiki
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki ( Site 3601)
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center ( Site 1710)
city: Ashkelon
country: Israel
facility: Barzilai Medical Center ( Site 1708)
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center ( Site 1705)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1711)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 1707)
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center ( Site 1703)
city: Ramat Gan
country: Israel
facility: Sheba MC ( Site 1701)
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
state: Friuli-Venezia Giulia
city: Milano
country: Italy
facility: Ospedale S. Giuseppe Multimedica ( Site 2403)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
state: Lombardia
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)
city: Roma
country: Italy
facility: Universita "La Sapienza" Policlinico Umberto I ( Site 2402)
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital ( Site 3105)
state: Kyonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 3103)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3102)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3106)
city: Seoul
country: Korea, Republic of
facility: The Catholic University Seoul St. Mary's Hospital ( Site 3104)
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)
state: Nuevo Leon
city: Sertoma
country: Mexico
facility: Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
state: Nuevo Leon
city: Huixquilucan
country: Mexico
facility: Hospital Angeles Lomas ( Site 2501)
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre ( Site 2605)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center ( Site 2603)
state: Limburg
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum ( Site 2601)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC ( Site 2604)
state: Zuid-Holland
city: Hamilton
country: New Zealand
facility: Waikato District Health Board ( Site 2702)
state: Waikato
city: Auckland
country: New Zealand
facility: Greenlane Clinical Centre ( Site 2703)
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
state: Malopolskie
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
state: Mazowieckie
city: Almada
country: Portugal
facility: Hospital Garcia de Orta ( Site 3501)
state: Setubal
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário De Coimbra ( Site 3502)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)
city: Sremska kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina ( Site 2906)
state: Juznobacki Okrug
city: Nis
country: Serbia
facility: University Clinical Center Nis ( Site 2904)
state: Nisavski Okrug
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac ( Site 2905)
state: Sumadijski Okrug
city: Beograd
country: Serbia
facility: Clinical Center of Serbia ( Site 2901)
city: Beograd
country: Serbia
facility: Institute of Cardiovascular Diseases Dedinje ( Site 2903)
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1601)
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario de Son Espases ( Site 1611)
state: Islas Baleares
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 1605)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 1602)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1603)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 1610)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1609)
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo ( Site 1607)
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund ( Site 3203)
state: Skane Lan
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
state: Uppsala Lan
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus ( Site 3205)
state: Vasterbottens Lan
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset ( Site 3201)
state: Vastra Gotalands Lan
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich ( Site 3301)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 3702)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 3701)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 3703)
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital ( Site 1208)
state: Cambridgeshire
city: London
country: United Kingdom
facility: Royal Brompton Hospital ( Site 1206)
state: England
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital ( Site 1204)
state: Glasgow City
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 1202)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust ( Site 1203)
state: London, City Of
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital ( Site 1207)
state: North Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: