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

PHASE3CompletedINTERVENTIONAL
Enrollment

321

Participants

Timeline

Start Date

March 18, 2022

Primary Completion Date

April 3, 2025

Study Completion Date

April 3, 2025

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Sotatercept

Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1

OTHER

Placebo

Placebo

Trial Locations (152)

161

La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402), Roma

704

National Cheng Kung University Hospital ( Site 3703), Tainan City

1070

Hopital Erasme ( Site 1402), Anderlecht

1090

Medizinische Universitat Wien ( Site 2001), Vienna

1878

Instituto de Investigaciones Clinicas Quilmes ( Site 1903), Quilmes

2002

Hospital Provincial del Centenario ( Site 1912), Rosario

2050

Royal Prince Alfred Hospital ( Site 1106), Camperdown

2100

Rigshospitalet ( Site 3802), København Ø

2308

John Hunter Hospital ( Site 1101), Newcastle

3000

UZ Gasthuisberg ( Site 1401), Leuven

3204

Waikato District Health Board ( Site 2702), Hamilton

4020

Ordensklinikum Linz GmbH Elisabethinen ( Site 2002), Linz

4032

Prince Charles Hospital ( Site 1104), Chermside

4102

Princess Alexandra Hospital ( Site 1108), Woolloongabba

5000

Royal Adelaide Hospital ( Site 1109), Adelaide

6020

Medizinische Universitat Innsbruck ( Site 2004), Innsbruck

6150

Fiona Stanley Hospital ( Site 1103), Murdoch

7000

Royal Hobart Hospital ( Site 1107), Hobart

8036

Medizinische Universität Graz ( Site 2003), Graz

8091

UniversitätsSpital Zürich ( Site 3301), Zurich

8200

Aarhus Universitetshospital, Skejby ( Site 3801), Aarhus

10000

Klinicki Bolnicki Centar Zagreb ( Site 3902), Zagreb

11000

Clinical Center of Serbia ( Site 2901), Belgrade

14033

CHU Caen Normandie ( Site 1325), Caen

14050

DRK Kliniken Berlin Westend ( Site 1507), Berlin

18000

University Clinical Center Nis ( Site 2904), Niš

20123

Ospedale S. Giuseppe Multimedica ( Site 2403), Milan

20900

Azienda Ospedaliera San Gerardo di Monza ( Site 2406), Monza

21000

University Hospital Centre Split city ( Site 3901), Split

21204

Institute for pulmonary diseases of Vojvodina ( Site 2906), Kamenitz

21565

Gachon University Gil Medical Center ( Site 3103), Namdong-Gu

22185

Skanes Universitetssjukhus Lund ( Site 3203), Lund

25000

CHU de Besancon ( Site 1303), Besançon

27514

University of North Carolina at Chapel Hill ( Site 1042), Chapel Hill

28041

Hospital Universitario 12 de Octubre ( Site 1603), Madrid

28046

Hospital Universitario La Paz ( Site 1610), Madrid

28222

Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604), Majadahonda

29200

Hopital Cavale Blanche ( Site 1314), Brest

30625

Medizinische Hochschule Hannover ( Site 1505), Hanover

31059

CHU de Toulouse - Hopital Larrey ( Site 1315), Toulouse

32804

AdventHealth Medical Group Advanced Lung Disease ( Site 1058), Orlando

33604

Hopital Haut Leveque ( Site 1312), Bordeaux

34000

Clinical Center Kragujevac ( Site 2905), Kragujevac

34149

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

35392

Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512), Bad Oeynhausen

37000

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

37007

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

37232

Vanderbilt University Medical Center ( Site 1027), Nashville

39008

Hospital Universitario Marques de Valdecilla ( Site 1601), Santander

40447

China Medical University Hospital ( Site 3701), Taichung

42270

Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302), Saint-Priest-en-Jarez

44000

Hopital Nord Laennec ( Site 1309), Nantes

44195

The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065), Cleveland

45004

Hospital Virgen de la Salud ( Site 1607), Toledo

45219

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001), Cincinnati

University of Cincinnati ( Site 1035), Cincinnati

48109

University of Michigan ( Site 1011), Ann Arbor

49933

CHU Angers ( Site 1313), Angers

50034

Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402), Medellín

50937

Uniklinik Köln ( Site 1511), Cologne

52242

University of Iowa Hospital and Clinics ( Site 1050), Iowa City

52621

Sheba Medical Center ( Site 1701), Tel Litwinsky

54500

C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308), Vandœuvre-lès-Nancy

61469

Chonnam National University Hospital ( Site 3105), Gwangju

63110

Washington University School of Medicine ( Site 1022), St Louis

66160

University of Kansas Medical Center ( Site 1020), Kansas City

66421

Universitatsklinikum des Saarlandes ( Site 1513), Homburg

67000

Hopitaux Universitaires de Strasbourg ( Site 1307), Strasbourg

69003

Hopital Louis Pradel ( Site 1317), Lyon

69120

Universitaetsklinikum Heidelberg ( Site 1509), Heidelberg

78701

University of Texas Southwestern Medical Center ( Site 1038), Dallas

80045

University of Colorado Hospital ( Site 1013), Aurora

80131

Azienda Ospedaliera R. N. V. Monaldi ( Site 2407), Napoli

80639

Krankenhaus Neuwittelsbach ( Site 1510), Munich

81362

Kaohsiung Veterans General Hospital ( Site 3702), Kaohsiung City

85258

Arizona Pulmonary Specialists ( Site 1010), Scottsdale

85724

University of Arizona ( Site 1006), Tucson

86000

CHU de Poitiers ( Site 1316), Poitiers

87131

University of New Mexico, Health Sciences Center ( Site 1048), Albuquerque

90095

UCLA Medical Center ( Site 1068), Los Angeles

90185

Norrlands Universitetssjukhus ( Site 3205), Umeå

92037

University of California San Diego ( Site 1002), La Jolla

92868

University of California Irvine ( Site 1086), Orange

93053

Universitaetsklinik Regensburg ( Site 1503), Regensburg

94270

CHU - Hopital de Bicetre ( Site 1304), Le Kremlin-Bicêtre

95817

University of California Davis Medical Center ( Site 1064), Sherman Oaks

97239

Oregon Health & Science University ( Site 1054), Portland

110131

Fundacion Neumologica Colombiana ( Site 3403), Bogota

760032

Fundacion Valle Del Lili ( Site 3401), Santiago de Cali

760042

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

3436212

Lady Davis Carmel Medical Center ( Site 1705), Haifa

7747629

Assuta Ashdod Medical Center ( Site 1710), Ashdod

9112001

Hadassah Medical Center ( Site 1711), Jerusalem

93105-5316

Santa Barbara Pulmonary Associates ( Site 1060), Santa Barbara

21287-0005

Johns Hopkins Hospital ( Site 1036), Baltimore

02111-1526

Tufts Medical Center - PPDS ( Site 1014), Boston

02118

Boston Medical Center ( Site 1012), Boston

10016-9196

NYU Langone Health ( Site 1052), New York

73112-4421

Nazih Zuhdi Transplantation Institute ( Site 1084), Oklahoma City

29425-8900

Medical University of South Carolina ( Site 1003), Charleston

84132-0001

University of Utah ( Site 1049), Salt Lake City

C1425BNG

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

C1426ABP

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

B1629ODT

Hospital Universitario Austral ( Site 1901), Pilar

B1853AIK

Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910), Villa Vatteone

5003DCE

Instituto Médico DAMIC ( Site 1909), Córdoba

X5800AEV

Instituto Medico Rio Cuarto ( Site 1907), Río Cuarto

S2000DSR

Instituto Cardiovascular de Rosario ( Site 1906), Rosario

S2000DSV

Sanatorio Parque ( Site 1905), Rosario

X5021FPQ

Sanatorio Allende ( Site 1908), Córdoba

S3000EOZ

Hospital Provincial Dr. Jose M. Cullen ( Site 1902), Santa Fe

30430-142

Hospital Madre Teresa ( Site 1804), Belo Horizonte

90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805), Porto Alegre

04038-031

Hospital Sao Paulo ( Site 1806), São Paulo

05403-000

Instituto do Coracao - HCFMUSP ( Site 1803), São Paulo

T6G 2B7

University of Alberta Hospital ( Site 2101), Edmonton

R2H 2A6

St Boniface General Hospital ( Site 2106), Winnepeg

L8N 4A6

McMaster University - HSC ( Site 2105), Hamilton

H3T 1E2

Sir Mortimer B Davis Jewish General Hospital ( Site 2103), Montreal

140 21

Institut Klinicke a Experimentalni Mediciny ( Site 2202), Prague

128 08

Vseobecna fakultni nemocnice v Praze ( Site 2201), Prague

06001

Hopital Louis Pasteur ( Site 1311), Nice

01307

Universitaetsklinikum Carl Gustav Carus ( Site 1501), Dresden

04103

Universitatsklinikum Leipzig ( Site 1508), Leipzig

06120

Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502), Halle

106 76

Evangelismos General Hospital of Athens ( Site 3605), Athens

176 74

Onassis Cardiac Surgery Center ( Site 3602), Athens

124 62

Attikon University General Hospital of Athens ( Site 3604), Haidari

546 36

AHEPA University General Hospital of Thessaloniki ( Site 3601), Thessaloniki

6500 HB

Radboud University Nijmegen Medical Centre ( Site 2605), Nijmegen

6229 HX

Maastricht University Medical Center ( Site 2603), Maastricht

1081 HV

VU Medisch Centrum ( Site 2601), Amsterdam

3015 GD

Erasmus MC ( Site 2604), Rotterdam

31-202

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

01-138

Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802), Warsaw

2801-951

Hospital Garcia de Orta ( Site 3501), Almada

3000-075

Centro Hospitalar E Universitário De Coimbra ( Site 3502), Coimbra

1769-001

Hospital Pulido Valente ( Site 3503), Lisbon

06351

Samsung Medical Center ( Site 3106), Seuol

03080

Seoul National University Hospital ( Site 3102), Seoul

03722

Severance Hospital Yonsei University Health System - PPDS ( Site 3101), Seoul

06591

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

07120

Hospital Universitario de Son Espases ( Site 1611), Palma de Mallorca

08035

Hospital Universitari Vall de Hebron ( Site 1605), Barcelona

751 85

Hjart-lungmedicin och klinisk fysiologi ( Site 3204), Uppsala

CB23 0AY

Papworth Hospital NHS Foundation Trust ( Site 1208), Cambrigge

S10 2JF

Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207), Sheffield

G81 4DY

Golden Jubilee National Hospital ( Site 1204), Glasgow

NW3 2QG

Royal Free London NHS Foundation Trust ( Site 1202), London

SW3 6HP

Royal Brompton Hospital ( Site 1206), London

W12 OHS

Imperial College Healthcare NHS Trust ( Site 1203), London

NE7 7DN

Freeman Hospital ( Site 1205), Newcastle upon Tyne

All Listed Sponsors
lead

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY