A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004)

Study Purpose

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants must have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early. 2. Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements. 3. Participants must have the ability to understand and provide documented informed consent. 4. Females of childbearing potential must: 1. 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. 2. 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. 3. 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. 5. Male participants must: 1. 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. 2. 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. 6. 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:

1. Not enrolled in a PAH parent study at the time of enrollment. 2. Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. 3. 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. 4. Pregnant or breastfeeding females.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04796337
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Serbia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, PAH
Additional Details

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.

Arms & Interventions

Arms

Experimental: Sotatercept Treatment

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.

Interventions

Biological: - Sotatercept

Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Active, not recruiting

Address

Arizona Pulmonary Specialists ( Site 1010)

Phoenix, Arizona, 85012-2369

Pulmonary Associates, PA ( Site 1008), Phoenix, Arizona

Status

Active, not recruiting

Address

Pulmonary Associates, PA ( Site 1008)

Phoenix, Arizona, 85032

University of Arizona ( Site 1006), Tucson, Arizona

Status

Active, not recruiting

Address

University of Arizona ( Site 1006)

Tucson, Arizona, 85724

La Jolla, California

Status

Active, not recruiting

Address

University of California San Diego ( Site 1002)

La Jolla, California, 92037

UC Davis - Medial Center ( Site 1064), Sacramento, California

Status

Recruiting

Address

UC Davis - Medial Center ( Site 1064)

Sacramento, California, 95817-2201

Site Contact

Study Coordinator

Trialsites@merck.com

713-704-4000

San Francisco, California

Status

Active, not recruiting

Address

University of California San Francisco ( Site 1019)

San Francisco, California, 94118

Harbor UCLA Medical Center ( Site 1028), Torrance, California

Status

Recruiting

Address

Harbor UCLA Medical Center ( Site 1028)

Torrance, California, 90502-2006

Site Contact

Study Coordinator

Trialsites@merck.com

310-222-3560

Aurora, Colorado

Status

Active, not recruiting

Address

University of Colorado Hospital ( Site 1013)

Aurora, Colorado, 80045

Washington, District of Columbia

Status

Recruiting

Address

The George Washington University Medical Faculty Associates ( Site 1025)

Washington, District of Columbia, 20037

Site Contact

Study Coordinator

Trialsites@merck.com

202-741-3624

Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Jacksonville - PPDS ( Site 1045)

Jacksonville, Florida, 32224

Site Contact

Study Coordinator

Trialsites@merck.com

904-953-2232

AdventHealth Orlando ( Site 1058), Orlando, Florida

Status

Recruiting

Address

AdventHealth Orlando ( Site 1058)

Orlando, Florida, 32803

Site Contact

Study Coordinator

Trialsites@merck.com

407-303-7556

University of South Florida ( Site 1043), Tampa, Florida

Status

Recruiting

Address

University of South Florida ( Site 1043)

Tampa, Florida, 33612

Site Contact

Study Coordinator

Trialsites@merck.com

813-259-0826

Emory University ( Site 1030), Atlanta, Georgia

Status

Recruiting

Address

Emory University ( Site 1030)

Atlanta, Georgia, 30322-1013

Site Contact

Study Coordinator

Trialsites@merck.com

404-712-1370

Louisville, Kentucky

Status

Recruiting

Address

Norton Pulmonary Specialists ( Site 1066)

Louisville, Kentucky, 40205

Site Contact

Study Coordinator

Trialsites@merck.com

502-629-3102

Tufts Medical Center - PPDS ( Site 1012), Boston, Massachusetts

Status

Active, not recruiting

Address

Tufts Medical Center - PPDS ( Site 1012)

Boston, Massachusetts, 02111-1526

Brigham & Women's Hospital ( Site 1014), Boston, Massachusetts

Status

Active, not recruiting

Address

Brigham & Women's Hospital ( Site 1014)

Boston, Massachusetts, 02115

University of Michigan ( Site 1011), Ann Arbor, Michigan

Status

Active, not recruiting

Address

University of Michigan ( Site 1011)

Ann Arbor, Michigan, 48109-5936

University of Minnesota ( Site 1062), Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota ( Site 1062)

Minneapolis, Minnesota, 55455

Site Contact

Study Coordinator

Trialsites@merck.com

612-827-1131

Kansas City, Missouri

Status

Active, not recruiting

Address

University of Kansas Medical Center ( Site 1020)

Kansas City, Missouri, 66160-7232

Saint Louis, Missouri

Status

Recruiting

Address

Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)

Saint Louis, Missouri, 63108-1495

Site Contact

Study Coordinator

Trialsites@merck.com

314-454-8766

Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center ( Site 1053)

Omaha, Nebraska, 68118

Site Contact

Study Coordinator

Trialsites@merck.com

402-559-7182

Reno, Nevada

Status

Recruiting

Address

Renown Regional Medical Center ( Site 1055)

Reno, Nevada, 89502-1262

Site Contact

Study Coordinator

Trialsites@merck.com

775-982-2400

New York, New York

Status

Active, not recruiting

Address

New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)

New York, New York, 10065

Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center - PPDS ( Site 1039)

Rochester, New York, 14642

Site Contact

Study Coordinator

Trialsites@merck.com

585-275-7434

Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center ( Site 1026)

Durham, North Carolina, 27710

Site Contact

Study Coordinator

Trialsites@merck.com

919-668-2642

Cincinnati, Ohio

Status

Active, not recruiting

Address

The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)

Cincinnati, Ohio, 45219

Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati Medical Center ( Site 1035)

Cincinnati, Ohio, 45219

Site Contact

Study Coordinator

Trialsites@merck.com

513-558-3975

Columbus, Ohio

Status

Active, not recruiting

Address

The Ohio State University Wexner Medical Center ( Site 1032)

Columbus, Ohio, 43221

Portland, Oregon

Status

Recruiting

Address

The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)

Portland, Oregon, 97239

Site Contact

Study Coordinator

Trialsites@merck.com

503-297-3778

Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)

Pittsburgh, Pennsylvania, 15213

Site Contact

Study Coordinator

Trialsites@merck.com

412-623-4147

Rhode Island Hospital ( Site 1033), Providence, Rhode Island

Status

Active, not recruiting

Address

Rhode Island Hospital ( Site 1033)

Providence, Rhode Island, 02903

Mount Pleasant, South Carolina

Status

Active, not recruiting

Address

Medical University of South Carolina - PPDS ( Site 1003)

Mount Pleasant, South Carolina, 29464-3771

Knoxville, Tennessee

Status

Recruiting

Address

Statcare Pulmonary Consultants - Knoxville ( Site 1031)

Knoxville, Tennessee, 37919

Site Contact

Study Coordinator

Trialsites@merck.com

941-924-9800

Houston, Texas

Status

Recruiting

Address

CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)

Houston, Texas, 77030

Site Contact

Study Coordinator

Trialsites@merck.com

832-355-1000

Houston Methodist Hospital ( Site 1009), Houston, Texas

Status

Active, not recruiting

Address

Houston Methodist Hospital ( Site 1009)

Houston, Texas, 77030

Seattle, Washington

Status

Recruiting

Address

University of Washington Medical Center ( Site 1067)

Seattle, Washington, 98195-0001

Site Contact

Study Coordinator

Trialsites@merck.com

206-598-4477

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

Milwaukee, Wisconsin, 53226

Site Contact

Study Coordinator

Trialsites@merck.com

414-805-6444

International Sites

Cardiologia Palermo ( Site 1911), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

Cardiologia Palermo ( Site 1911)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BNG

Site Contact

Study Coordinator

Trialsites@merck.com

+541148339060

Quilmes, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, B1878GEG

Site Contact

Study Coordinator

Trialsites@merck.com

+541142531337

Centro Medico Dra De Salvo ( Site 1904), Ciudad Autonoma de Buenos Aires, Caba, Argentina

Status

Recruiting

Address

Centro Medico Dra De Salvo ( Site 1904)

Ciudad Autonoma de Buenos Aires, Caba, C1426ABP

Site Contact

Study Coordinator

Trialsites@merck.com

+541147815331

Instituto Médico DAMIC ( Site 1909), Córdoba, Cordoba, Argentina

Status

Recruiting

Address

Instituto Médico DAMIC ( Site 1909)

Córdoba, Cordoba, 5003DCE

Site Contact

Study Coordinator

Trialsites@merck.com

+54 351 4888230

Instituto Medico Rio Cuarto ( Site 1907), Rio Cuarto, Cordoba, Argentina

Status

Recruiting

Address

Instituto Medico Rio Cuarto ( Site 1907)

Rio Cuarto, Cordoba, X5800AEV

Site Contact

Study Coordinator

Trialsites@merck.com

+543584679333

Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Centro Oncologico de Rosario ( Site 1905)

Rosario, Santa Fe, 2000

Site Contact

Study Coordinator

Trialsites@merck.com

+543414268409

Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Hospital Provincial del Centenario ( Site 1912)

Rosario, Santa Fe, 2002

Site Contact

Study Coordinator

Trialsites@merck.com

+543414375807

Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Instituto Cardiovascular de Rosario ( Site 1906)

Rosario, Santa Fe, S2000DSR

Site Contact

Study Coordinator

Trialsites@merck.com

+543414203040

Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Universitario Austral ( Site 1901)

Buenos Aires, , B1629AHJ

Site Contact

Study Coordinator

Trialsites@merck.com

+5491160149487

Sanatorio Allende ( Site 1908), Cordoba, Argentina

Status

Recruiting

Address

Sanatorio Allende ( Site 1908)

Cordoba, , X5000JHQ

Site Contact

Study Coordinator

Trialsites@merck.com

+543514250526

Santa Fe, Argentina

Status

Recruiting

Address

Hospital Dr. Jose Maria Cullen ( Site 1902)

Santa Fe, , S3000EOZ

Site Contact

Study Coordinator

Trialsites@merck.com

+543424528250

Camperdown, New South Wales, Australia

Status

Active, not recruiting

Address

Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, 2050

Darlinghurst, New South Wales, Australia

Status

Active, not recruiting

Address

Saint Vincents Hospital Sydney ( Site 1102)

Darlinghurst, New South Wales, 2010

John Hunter Hospital ( Site 1101), New Lambton, New South Wales, Australia

Status

Active, not recruiting

Address

John Hunter Hospital ( Site 1101)

New Lambton, New South Wales, 2305

The Prince Charles Hospital ( Site 1104), Brisbane, Queensland, Australia

Status

Active, not recruiting

Address

The Prince Charles Hospital ( Site 1104)

Brisbane, Queensland, 4032

Royal Adelaide Hospital ( Site 1109), Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital ( Site 1109)

Adelaide, South Australia, 5000

Site Contact

Study Coordinator

Trialsites@merck.com

+61870745244

Royal Hobart Hospital ( Site 1107), Hobart, Tasmania, Australia

Status

Recruiting

Address

Royal Hobart Hospital ( Site 1107)

Hobart, Tasmania, 7000

Site Contact

Study Coordinator

Trialsites@merck.com

+61361668308

Fiona Stanley Hospital ( Site 1103), Murdoch, Western Australia, Australia

Status

Recruiting

Address

Fiona Stanley Hospital ( Site 1103)

Murdoch, Western Australia, 6150

Site Contact

Study Coordinator

Trialsites@merck.com

+61861511154

Linz, Oberosterreich, Austria

Status

Recruiting

Address

Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)

Linz, Oberosterreich, 4020

Site Contact

Study Coordinator

Trialsites@merck.com

+4373276764916

Graz, Steiermark, Austria

Status

Recruiting

Address

Medizinische Universität Graz ( Site 2003)

Graz, Steiermark, 8036

Site Contact

Study Coordinator

Trialsites@merck.com

+433163809618

Innsbruck, Tirol, Austria

Status

Recruiting

Address

Medizinische Universitat Innsbruck ( Site 2004)

Innsbruck, Tirol, 6020

Site Contact

Study Coordinator

Trialsites@merck.com

+4351250481413

Wien, Austria

Status

Recruiting

Address

Medizinische Universitat Wien ( Site 2001)

Wien, , 1090

Site Contact

Study Coordinator

Trialsites@merck.com

+4314040043910

Erasme Hospital ( Site 1402), Bruxelles, Bruxelles-Capitale, Region De, Belgium

Status

Recruiting

Address

Erasme Hospital ( Site 1402)

Bruxelles, Bruxelles-Capitale, Region De, 1070

Site Contact

Study Coordinator

Trialsites@merck.com

+3225553111

Leuven, Vlaams-Brabant, Belgium

Status

Active, not recruiting

Address

UZ Leuven - Campus Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, 3000

Hospital Madre Teresa ( Site 1804), Belo Horizonte, Minas Gerais, Brazil

Status

Active, not recruiting

Address

Hospital Madre Teresa ( Site 1804)

Belo Horizonte, Minas Gerais, 30430-142

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Active, not recruiting

Address

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)

Porto Alegre, Rio Grande Do Sul, 90035-074

Hospital São Lucas da PUCRS ( Site 1801), Porto Alegre, Rio Grande Do Sul, Brazil

Status

Active, not recruiting

Address

Hospital São Lucas da PUCRS ( Site 1801)

Porto Alegre, Rio Grande Do Sul, 90610-000

Hospital Dia do Pulmao ( Site 1802), Blumenau, Santa Catarina, Brazil

Status

Active, not recruiting

Address

Hospital Dia do Pulmao ( Site 1802)

Blumenau, Santa Catarina, 89010-000

Hospital Sao Paulo ( Site 1806), São Paulo, Sao Paulo, Brazil

Status

Active, not recruiting

Address

Hospital Sao Paulo ( Site 1806)

São Paulo, Sao Paulo, 04038-031

Sao Paulo, Brazil

Status

Active, not recruiting

Address

Instituto do Coracao - HCFMUSP ( Site 1803)

Sao Paulo, , 05403-000

Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital ( Site 2101)

Edmonton, Alberta, T6G 2B7

Site Contact

Study Coordinator

Trialsites@merck.com

7804071586

Winnepeg, Manitoba, Canada

Status

Recruiting

Address

St Boniface General Hospital ( Site 2106)

Winnepeg, Manitoba, R2H 2A6

Site Contact

Study Coordinator

Trialsites@merck.com

2042338563

Jewish General Hospital ( Site 2103), Montreal, Quebec, Canada

Status

Recruiting

Address

Jewish General Hospital ( Site 2103)

Montreal, Quebec, H3T 1E2

Site Contact

Study Coordinator

Trialsites@merck.com

5143407531

Santiago de Cali, Valle Del Cauca, Colombia

Status

Recruiting

Address

Centro Medico Imbanaco de Cali S.A ( Site 3404)

Santiago de Cali, Valle Del Cauca, 760042

Site Contact

Study Coordinator

Trialsites@merck.com

+573138534831

Split, Splitsko-dalmatinska Zupanija, Croatia

Status

Recruiting

Address

Klinički Bolnički Centar Split ( Site 3901)

Split, Splitsko-dalmatinska Zupanija, 21000

Site Contact

Study Coordinator

Trialsites@merck.com

+385 021556129

Zagreb, Zagrebacka Zupanija, Croatia

Status

Recruiting

Address

Klinicki Bolnicki Centar Zagreb ( Site 3902)

Zagreb, Zagrebacka Zupanija, 10000

Site Contact

Study Coordinator

Trialsites@merck.com

+38512385283

Praha 2, Czechia

Status

Active, not recruiting

Address

Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)

Praha 2, , 128 08

Praha 4, Czechia

Status

Recruiting

Address

Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)

Praha 4, , 140 21

Site Contact

Study Coordinator

Trialsites@merck.com

+420261363387

Rigshospitalet ( Site 3802), København Ø, Hovedstaden, Denmark

Status

Recruiting

Address

Rigshospitalet ( Site 3802)

København Ø, Hovedstaden, 2100

Site Contact

Study Coordinator

Trialsites@merck.com

+4535457752

Aarhus, Midtjylland, Denmark

Status

Recruiting

Address

Aarhus Universitetshospital, Skejby ( Site 3801)

Aarhus, Midtjylland, 8200

Site Contact

Study Coordinator

Trialsites@merck.com

+4578450000

Nice, Alpes-Maritimes, France

Status

Active, not recruiting

Address

Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)

Nice, Alpes-Maritimes, 06001

Strasbourg, Bas-Rhin, France

Status

Recruiting

Address

Hopital Civil - CHU Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, 67000

Site Contact

Study Coordinator

Trialsites@merck.com

+33369550345

Hopital cote de Nacre ( Site 1325), Caen, Calvados, France

Status

Recruiting

Address

Hopital cote de Nacre ( Site 1325)

Caen, Calvados, 14000

Site Contact

Study Coordinator

Trialsites@merck.com

+33231064677

Hopital Cavale Blanche ( Site 1314), Brest, Finistere, France

Status

Recruiting

Address

Hopital Cavale Blanche ( Site 1314)

Brest, Finistere, 29200

Site Contact

Study Coordinator

Trialsites@merck.com

+33298347600

Groupe Hospitalier Sud ( Site 1312), Pessac, Gironde, France

Status

Recruiting

Address

Groupe Hospitalier Sud ( Site 1312)

Pessac, Gironde, 33600

Site Contact

Study Coordinator

Trialsites@merck.com

+33557656439

Toulouse, Haute-Garonne, France

Status

Recruiting

Address

CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, 31400

Site Contact

Study Coordinator

Trialsites@merck.com

+33567771793

Montpellier, Herault, France

Status

Active, not recruiting

Address

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)

Montpellier, Herault, 34090

Tours, Indre-et-Loire, France

Status

Recruiting

Address

C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

Tours, Indre-et-Loire, 37000

Site Contact

Study Coordinator

Trialsites@merck.com

+33247473714

La Tronche, Isere, France

Status

Active, not recruiting

Address

C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)

La Tronche, Isere, 38700

Hopital Nord Laennec ( Site 1309), Nantes, Loire-Atlantique, France

Status

Recruiting

Address

Hopital Nord Laennec ( Site 1309)

Nantes, Loire-Atlantique, 44000

Site Contact

Study Coordinator

Trialsites@merck.com

+33240165235

Saint-Priest-en-Jarez, Loire, France

Status

Active, not recruiting

Address

Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

Saint-Priest-en-Jarez, Loire, 42055

CHU Angers ( Site 1313), Angers, Maine-et-Loire, France

Status

Active, not recruiting

Address

CHU Angers ( Site 1313)

Angers, Maine-et-Loire, 49933

Vandoeuvre Les Nancy, Meurthe-et-Moselle, France

Status

Recruiting

Address

C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

Vandoeuvre Les Nancy, Meurthe-et-Moselle, 54500

Site Contact

Study Coordinator

Trialsites@merck.com

+33383154405

CHRU Lille ( Site 1306), Lille, Nord, France

Status

Active, not recruiting

Address

CHRU Lille ( Site 1306)

Lille, Nord, 59037

Bron, Rhone-Alpes, France

Status

Recruiting

Address

Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)

Bron, Rhone-Alpes, 69677

Site Contact

Study Coordinator

Trialsites@merck.com

+33472681301

CHU - Hopital de Bicetre ( Site 1304), Le Kremlin Bicetre, Val-de-Marne, France

Status

Active, not recruiting

Address

CHU - Hopital de Bicetre ( Site 1304)

Le Kremlin Bicetre, Val-de-Marne, 94270

CHU de la Miletrie Poitiers ( Site 1316), Poitiers, Vienne, France

Status

Recruiting

Address

CHU de la Miletrie Poitiers ( Site 1316)

Poitiers, Vienne, 86021

Site Contact

Study Coordinator

Trialsites@merck.com

+33549444689

Heidelberg, Baden-Wurttemberg, Germany

Status

Active, not recruiting

Address

Thoraxklinik-Heidelberg gGmbH ( Site 1509)

Heidelberg, Baden-Wurttemberg, 69126

Krankenhaus Neuwittelsbach ( Site 1510), München, Bayern, Germany

Status

Active, not recruiting

Address

Krankenhaus Neuwittelsbach ( Site 1510)

München, Bayern, 80639

Regensburg, Bayern, Germany

Status

Active, not recruiting

Address

Universitaetsklinik Regensburg ( Site 1503)

Regensburg, Bayern, 93053

Gießen, Hessen, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

Gießen, Hessen, 35392

Hannover, Niedersachsen, Germany

Status

Active, not recruiting

Address

Medizinische Hochschule Hannover ( Site 1505)

Hannover, Niedersachsen, 30625

Universitätsklinik Köln ( Site 1511), Cologne, Nordrhein-Westfalen, Germany

Status

Active, not recruiting

Address

Universitätsklinik Köln ( Site 1511)

Cologne, Nordrhein-Westfalen, 50931

Universataet des Saarlandes ( Site 1513), Homburg, Saarland, Germany

Status

Recruiting

Address

Universataet des Saarlandes ( Site 1513)

Homburg, Saarland, 66424

Site Contact

Study Coordinator

Trialsites@merck.com

+4968411621328

Universitätsklinikum Halle ( Site 1502), Halle, Sachsen-Anhalt, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Halle ( Site 1502)

Halle, Sachsen-Anhalt, 06120

Dresden, Sachsen, Germany

Status

Active, not recruiting

Address

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)

Dresden, Sachsen, 01307

Leipzig, Sachsen, Germany

Status

Active, not recruiting

Address

Universitatsklinikum Leipzig ( Site 1508)

Leipzig, Sachsen, 04103

DRK Kliniken Berlin Westend ( Site 1507), Berlin, Germany

Status

Recruiting

Address

DRK Kliniken Berlin Westend ( Site 1507)

Berlin, , 14050

Site Contact

Study Coordinator

Trialsites@merck.com

+493030350

Athens, Attiki, Greece

Status

Recruiting

Address

Attikon University General Hospital of Athens ( Site 3604)

Athens, Attiki, 124 62

Site Contact

Study Coordinator

Trialsites@merck.com

+306945468736

Athina, Attiki, Greece

Status

Recruiting

Address

Evangelismos General Hospital of Athens ( Site 3605)

Athina, Attiki, 106 76

Site Contact

Study Coordinator

Trialsites@merck.com

+302107201211

Thessaloniki, Greece

Status

Recruiting

Address

AHEPA University General Hospital of Thessaloniki ( Site 3601)

Thessaloniki, , 54636

Site Contact

Study Coordinator

Trialsites@merck.com

+302310993261

Barzilai Medical Center ( Site 1708), Ashkelon, Israel

Status

Active, not recruiting

Address

Barzilai Medical Center ( Site 1708)

Ashkelon, , 7830604

Haifa, Israel

Status

Active, not recruiting

Address

Lady Davis Carmel Medical Center ( Site 1705)

Haifa, , 34362

Hadassah Medical Center ( Site 1711), Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center ( Site 1711)

Jerusalem, , 9112001

Site Contact

Study Coordinator

Trialsites@merck.com

+97226777595

Meir Medical Center ( Site 1707), Kfar Saba, Israel

Status

Active, not recruiting

Address

Meir Medical Center ( Site 1707)

Kfar Saba, , 4428164

Rabin Medical Center ( Site 1703), Petach Tikvah, Israel

Status

Active, not recruiting

Address

Rabin Medical Center ( Site 1703)

Petach Tikvah, , 4941492

Sheba MC ( Site 1701), Ramat Gan, Israel

Status

Active, not recruiting

Address

Sheba MC ( Site 1701)

Ramat Gan, , 5265601

Trieste, Friuli-Venezia Giulia, Italy

Status

Recruiting

Address

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

Trieste, Friuli-Venezia Giulia, 34149

Site Contact

Study Coordinator

Trialsites@merck.com

+39 040 399 1111

Milano, Lombardia, Italy

Status

Recruiting

Address

Ospedale S. Giuseppe Multimedica ( Site 2403)

Milano, Lombardia, 20123

Site Contact

Study Coordinator

Trialsites@merck.com

+390285991

Roma, Italy

Status

Recruiting

Address

Universita "La Sapienza" Policlinico Umberto I ( Site 2402)

Roma, , 00161

Site Contact

Study Coordinator

Trialsites@merck.com

+390649979051

Gwangju, Kwangju-Kwangyokshi, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hospital ( Site 3105)

Gwangju, Kwangju-Kwangyokshi, 61469

Site Contact

Study Coordinator

Trialsites@merck.com

+82622205114

Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center ( Site 3103)

Incheon, , 21565

Site Contact

Study Coordinator

Trialsites@merck.com

+82324603663

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital ( Site 3102)

Seoul, , 03080

Site Contact

Study Coordinator

Trialsites@merck.com

+821091601357

Samsung Medical Center ( Site 3106), Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center ( Site 3106)

Seoul, , 06351

Site Contact

Study Coordinator

Trialsites@merck.com

+82234103892

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 3104)

Seoul, , 06591

Site Contact

Study Coordinator

Trialsites@merck.com

+82222586007

Sertoma, Nuevo Leon, Mexico

Status

Recruiting

Address

Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)

Sertoma, Nuevo Leon, 64718

Site Contact

Study Coordinator

Trialsites@merck.com

+528181430795

Hospital Angeles Lomas ( Site 2501), Huixquilucan, Mexico

Status

Recruiting

Address

Hospital Angeles Lomas ( Site 2501)

Huixquilucan, , 52763

Site Contact

Study Coordinator

Trialsites@merck.com

+525552470671

Nijmegen, Gelderland, Netherlands

Status

Recruiting

Address

Radboud University Nijmegen Medical Centre ( Site 2605)

Nijmegen, Gelderland, 6500 HB

Site Contact

Study Coordinator

Trialsites@merck.com

+31243616928

Erasmus MC ( Site 2604), Rotterdam, Gelderland, Netherlands

Status

Recruiting

Address

Erasmus MC ( Site 2604)

Rotterdam, Gelderland, 3015 GJ

Site Contact

Study Coordinator

Trialsites@merck.com

+31107033612

Maastricht, Limburg, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center ( Site 2603)

Maastricht, Limburg, 6229 HX

Site Contact

Study Coordinator

Trialsites@merck.com

+31433871049

VU Medisch Centrum ( Site 2601), Amsterdam, Noord-Holland, Netherlands

Status

Recruiting

Address

VU Medisch Centrum ( Site 2601)

Amsterdam, Noord-Holland, 1081 HV

Site Contact

Study Coordinator

Trialsites@merck.com

+31204444444

Hamilton, Waikato, New Zealand

Status

Recruiting

Address

Waikato District Health Board ( Site 2702)

Hamilton, Waikato, 3240

Site Contact

Study Coordinator

Trialsites@merck.com

+6478599180

Greenlane Clinical Centre ( Site 2703), Auckland, New Zealand

Status

Recruiting

Address

Greenlane Clinical Centre ( Site 2703)

Auckland, , 1051

Site Contact

Study Coordinator

Trialsites@merck.com

+6496389909

Krakow, Malopolskie, Poland

Status

Active, not recruiting

Address

Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

Krakow, Malopolskie, 31-202

Otwock, Mazowieckie, Poland

Status

Active, not recruiting

Address

Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)

Otwock, Mazowieckie, 05-400

Hospital Garcia de Orta ( Site 3501), Almada, Setubal, Portugal

Status

Recruiting

Address

Hospital Garcia de Orta ( Site 3501)

Almada, Setubal, 2801-267

Site Contact

Study Coordinator

Trialsites@merck.com

+351212940294

Coimbra, Portugal

Status

Recruiting

Address

Centro Hospitalar E Universitário De Coimbra ( Site 3502)

Coimbra, , 3000-075

Site Contact

Study Coordinator

Trialsites@merck.com

+351239400400

Lisboa, Portugal

Status

Recruiting

Address

Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 3503)

Lisboa, , 1769-001

Site Contact

Study Coordinator

Trialsites@merck.com

+351217548085

Sremska kamenica, Juznobacki Okrug, Serbia

Status

Recruiting

Address

Institute for pulmonary diseases of Vojvodina ( Site 2906)

Sremska kamenica, Juznobacki Okrug, 21204

Site Contact

Study Coordinator

Trialsites@merck.com

+381214805100

Nis, Nisavski Okrug, Serbia

Status

Recruiting

Address

University Clinical Center Nis ( Site 2904)

Nis, Nisavski Okrug, 18000

Site Contact

Study Coordinator

Trialsites@merck.com

+38118333752

Clinical Center Kragujevac ( Site 2905), Kragujevac, Sumadijski Okrug, Serbia

Status

Recruiting

Address

Clinical Center Kragujevac ( Site 2905)

Kragujevac, Sumadijski Okrug, 34000

Site Contact

Study Coordinator

Trialsites@merck.com

+38134370208

Clinical Center of Serbia ( Site 2901), Beograd, Serbia

Status

Recruiting

Address

Clinical Center of Serbia ( Site 2901)

Beograd, , 11000

Site Contact

Study Coordinator

Trialsites@merck.com

+381112685662

Beograd, Serbia

Status

Active, not recruiting

Address

Institute of Cardiovascular Diseases Dedinje ( Site 2903)

Beograd, , 11040

Santander, Cantabria, Spain

Status

Active, not recruiting

Address

Hospital Universitario Marques de Valdecilla ( Site 1601)

Santander, Cantabria, 39008

Palma de Mallorca, Islas Baleares, Spain

Status

Recruiting

Address

Hospital Universitario de Son Espases ( Site 1611)

Palma de Mallorca, Islas Baleares, 07120

Site Contact

Study Coordinator

Trialsites@merck.com

+34871205110

Majadahonda, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)

Majadahonda, Madrid, 28222

Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Universitari Vall d'Hebron ( Site 1605)

Barcelona, , 08035

Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Clinic de Barcelona ( Site 1602)

Barcelona, , 08036

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario Ramon y Cajal ( Site 1609)

Madrid, , 28034

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario 12 de Octubre ( Site 1603)

Madrid, , 28041

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz ( Site 1610)

Madrid, , 28046

Site Contact

Study Coordinator

Trialsites@merck.com

+34917271785

Salamanca, Spain

Status

Recruiting

Address

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

Salamanca, , 37007

Site Contact

Study Coordinator

Trialsites@merck.com

+34656675778

Toledo, Spain

Status

Recruiting

Address

Hospital Universitario de Toledo ( Site 1607)

Toledo, , 41007

Site Contact

Study Coordinator

Trialsites@merck.com

+34600162109

Lund, Skane Lan, Sweden

Status

Recruiting

Address

Skanes Universitetssjukhus Lund ( Site 3203)

Lund, Skane Lan, 221 85

Site Contact

Study Coordinator

Trialsites@merck.com

+464617141

Uppsala, Uppsala Lan, Sweden

Status

Recruiting

Address

Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)

Uppsala, Uppsala Lan, 751 85

Site Contact

Study Coordinator

Trialsites@merck.com

+46186110000

Umea, Vasterbottens Lan, Sweden

Status

Recruiting

Address

Norrlands Universitetssjukhus ( Site 3205)

Umea, Vasterbottens Lan, 90185

Site Contact

Study Coordinator

Trialsites@merck.com

+4690785000

Goteburg, Vastra Gotalands Lan, Sweden

Status

Recruiting

Address

Sahlgrenska Universitetssjukhuset ( Site 3201)

Goteburg, Vastra Gotalands Lan, 413 45

Site Contact

Study Coordinator

Trialsites@merck.com

+46313422929

Universitaetsspital Zurich ( Site 3301), Zurich, Switzerland

Status

Active, not recruiting

Address

Universitaetsspital Zurich ( Site 3301)

Zurich, , 8091

Kaohsiung, Taiwan

Status

Recruiting

Address

Kaohsiung Veterans General Hospital ( Site 3702)

Kaohsiung, , 813

Site Contact

Study Coordinator

Trialsites@merck.com

+88673468097

Taichung, Taiwan

Status

Recruiting

Address

China Medical University Hospital ( Site 3701)

Taichung, , 40447

Site Contact

Study Coordinator

Trialsites@merck.com

+886422052121

Tainan, Taiwan

Status

Recruiting

Address

National Cheng Kung University Hospital ( Site 3703)

Tainan, , 704

Site Contact

Study Coordinator

Trialsites@merck.com

+88663028130

Glasgow, Glasgow City, United Kingdom

Status

Active, not recruiting

Address

Golden Jubilee National Hospital ( Site 1204)

Glasgow, Glasgow City, G81 2DR

London, London, City Of, United Kingdom

Status

Active, not recruiting

Address

Royal Free London NHS Foundation Trust ( Site 1202)

London, London, City Of, NW3 2QG

Royal Brompton Hospital ( Site 1206), London, London, City Of, United Kingdom

Status

Active, not recruiting

Address

Royal Brompton Hospital ( Site 1206)

London, London, City Of, SW3 6NP

London, London, City Of, United Kingdom

Status

Active, not recruiting

Address

Imperial College Healthcare NHS Trust ( Site 1203)

London, London, City Of, W2 1PG

Royal Hallamshire Hospital ( Site 1207), Sheffield, North Yorkshire, United Kingdom

Status

Recruiting

Address

Royal Hallamshire Hospital ( Site 1207)

Sheffield, North Yorkshire, S10 2JF

Site Contact

Study Coordinator

Trialsites@merck.com

+441142712566

Papworth Hospital ( Site 1208), Cambridgeshire, United Kingdom

Status

Recruiting

Address

Papworth Hospital ( Site 1208)

Cambridgeshire, , CB23 8RE

Site Contact

Study Coordinator

Trialsites@merck.com

+441480830541

Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)

Newcastle Upon Tyne, , NE7 7DN

Site Contact

Study Coordinator

Trialsites@merck.com

+441912137489

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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