A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (CADENCE)

April 25, 2024 updated by: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period. In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Bruxelles-Capitale, Region De
      • Anderlecht, Bruxelles-Capitale, Region De, Belgium, 1070
        • Recruiting
        • Hôpital Erasme ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +3225553111
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven - Campus Gasthuisberg ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216341245
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University Of Alberta ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: (780) 407-1586
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110)
        • Contact:
          • Study Coordinator
          • Phone Number: (905) 524-2424
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network c/o Toronto General Hospital ( Site 2109)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-340-4043
    • Quebec
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: 418-656-8711
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • Recruiting
        • Hôpital Pasteur - CHU Nice ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492038473
    • Doubs
      • Besançon, Doubs, France, 25000
        • Recruiting
        • Centre Hospitalier Universitaire du Besancon ( Site 1324)
        • Contact:
          • Study Coordinator
          • Phone Number: +33381668624
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • Recruiting
        • Hopital de Rangueil du Toulouse ( Site 1322)
        • Contact:
          • Study Coordinator
          • Phone Number: +33561323240
    • Herault
      • Montpellier, Herault, France, 34090
        • Recruiting
        • CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 4 67 33 67 33
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Recruiting
        • Hôpital Pontchaillou ( Site 1319)
        • Contact:
          • Study Coordinator
          • Phone Number: +33299282525
    • Isere
      • Grenoble cedex 09, Isere, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire de Grenoble ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +33476765523
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • CHU de Nantes - Hoptal Nord Laennec ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +33240165023
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Recruiting
        • CHU Angers ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: +33241353695
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • Recruiting
        • CHRU de Nancy Hopitaux de Brabois ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +33383154021
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CHRU Lille ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320446011
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • Recruiting
        • CHU de Rouen ( Site 1323)
        • Contact:
          • Study Coordinator
          • Phone Number: 33232888207
    • Val-de-Marne
      • Le Kremlin Bicêtre, Val-de-Marne, France, 94270
        • Recruiting
        • Centre Hospitalier Universitaire de Bicetre ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +33145212121
  • Germany
      • Berlin, Germany, 14050
        • Recruiting
        • DRK Kliniken Berlin Westend ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 3030354305
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg gGmbH ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 6221 3960
    • Bayern
      • München, Bayern, Germany, 80639
        • Recruiting
        • Krankenhaus Neuwittelsbach ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 89 13040
      • Regensburg, Bayern, Germany, 93053
        • Recruiting
        • University Hospital Regensburg ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +49941944489
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Recruiting
        • Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)
        • Contact:
          • Study Coordinator
          • Phone Number: +4960329962135
      • Gießen, Hessen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
        • Contact:
          • Study Coordinator
          • Phone Number: +496419945113
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +495115329184
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 50931
        • Recruiting
        • Uniklinik Köln ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: +492214785860
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515)
        • Contact:
          • Study Coordinator
          • Phone Number: +496131170
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +493514585089
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center ( Site 1710)
        • Contact:
          • Study Coordinator
          • Phone Number: 972532227937
      • Be'er Ya'akov, Israel, 7030001
        • Recruiting
        • Shamir Medical Center Assaf Harofeh ( Site 1713)
        • Contact:
          • Study Coordinator
          • Phone Number: +97289779999
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Corp. ( Site 1716)
        • Contact:
          • Study Coordinator
          • Phone Number: +97248542181
      • Haifa, Israel, 3436212
        • Recruiting
        • Lady Davis Carmel Medical Center ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +97248342707
      • Holon, Israel, 58100
        • Recruiting
        • Edith Wolfson Medical Center ( Site 1717)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235011991
      • Jerusalem, Israel, 9574425
        • Recruiting
        • Hadassah Ein Kerem Medical Center ( Site 1711)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226777595
      • Jerusalem, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1715)
        • Contact:
          • Study Coordinator
          • Phone Number: 972508685209
      • Petah Tiqwa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239376751
      • Rehovot, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center ( Site 1712)
        • Contact:
          • Study Coordinator
          • Phone Number: +97289440040
      • Safed, Israel, 13100
        • Recruiting
        • ZIV Medical Center ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +97246828943
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center ( Site 1714)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236973776
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII ( Site 2410)
        • Contact:
          • Study Coordinator
          • Phone Number: +390352675027
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Policlinico Umberto I ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +390649970382
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409)
        • Contact:
          • Study Coordinator
          • Phone Number: +39051453104
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
        • Recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: 39 040 399 1111
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +3903923311
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS-Policlinico San Matteo ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +390382503777
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • Recruiting
        • Ospedale SS Annunziata ( Site 2408)
        • Contact:
          • Study Coordinator
          • Phone Number: 079 2061531939
  • Poland
    • Lubelskie
      • Lubin, Lubelskie, Poland, 20-718
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806)
        • Contact:
          • Study Coordinator
          • Phone Number: +48815374556
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-202
        • Recruiting
        • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +48126143501
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Recruiting
        • Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +48227103010
      • Warszawa, Mazowieckie, Poland, 02-507
        • Recruiting
        • Państwowy Instytut Medyczny MSWiA ( Site 2805)
        • Contact:
          • Study Coordinator
          • Phone Number: +0048502133158
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-111
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804)
        • Contact:
          • Study Coordinator
          • Phone Number: +48914661197
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275786
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914692313
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena ( Site 1612)
        • Contact:
          • Study Coordinator
          • Phone Number: +34600162109
      • Toledo, Spain, 41007
        • Recruiting
        • Hospital Universitario de Toledo ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: +34600162109
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +34911917418
  • Sweden
    • Vastra Gotalands Lan
      • Goteburg, Vastra Gotalands Lan, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +46313422929
  • United Kingdom
    • London, City Of
      • London, London, City Of, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 3311 3311
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • PULMONARY ASSOCIATES, P.A. ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-258-4951
      • Tucson, Arizona, United States, 85724-0001
        • Recruiting
        • University of Arizona ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-626-8000
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center ( Site 1082)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-423-3713
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine ( Site 1086)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-824-6256
      • Santa Barbara, California, United States, 93105-5311
        • Recruiting
        • Jeffrey S.Sager MD Medical Corporation ( Site 1060)
        • Contact:
          • Study Coordinator
          • Phone Number: 805-845-1500
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford University ( Site 1024)
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-222-3560
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado ( Site 1013)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-2786
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • South Denver Cardiology Associates ( Site 1091)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-715-2210
    • Connecticut
      • New Haven, Connecticut, United States, 06519-1304
        • Recruiting
        • Winchester Chest Clinic ( Site 1093)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-688-1861
    • District of Columbia
      • Washington, District of Columbia, United States, 20037-3201
        • Recruiting
        • The George Washington University Medical Faculty Associates ( Site 1025)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-741-3624
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Bay Area Cardiology ( Site 1071)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-684-6000
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville - PPDS ( Site 1045)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-2381
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando ( Site 1058)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-303-7556
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital ( Site 1043)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-259-0826
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Emory University ( Site 1030)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-712-1370
      • Atlanta, Georgia, United States, 30309-1281
        • Recruiting
        • Piedmont Atlanta Hospital ( Site 1085)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-948-6041
    • Idaho
      • Boise, Idaho, United States, 83704-8880
        • Recruiting
        • Saint Alphonsus Regional Medical Center ( Site 1097)
        • Contact:
          • Study Coordinator
          • Phone Number: 208-367-7676
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital ( Site 1095)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-355-5918
    • Indiana
      • Indianapolis, Indiana, United States, 46202-1218
        • Recruiting
        • IU Health Advanced Heart and Lung Care ( Site 1092)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-962-9700
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension Medical Group St. Vincent ( Site 1076)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-338-6666
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospital and Clinics ( Site 1050)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2577
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center ( Site 1020)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-588-2314
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Pulmonary Specialists ( Site 1066)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans ( Site 1057)
        • Contact:
          • Study Coordinator
          • Phone Number: 504-903-7302
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center - PPDS ( Site 1012)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-636-2892
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Brigham and Women's Hospital [Boston, MA] ( Site 1014)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-525-1267
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-232-3741
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Completed
        • University of Minnesota Hospitals ( Site 1062)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine [Saint Louis, MO] ( Site 1022)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-747-8174
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-559-7182
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Pulmonary Health Physicians ( Site 1080)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-475-8402
      • New York, New York, United States, 10021-9800
        • Recruiting
        • Weill Cornell Medical College ( Site 1046)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-746-6645
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center - PPDS ( Site 1039)
        • Contact:
          • Study Coordinator
          • Phone Number: 585-275-7434
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke University Medical Center ( Site 1026)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-668-2646
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 515-585-1777
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-844-2878
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-2200
      • Toledo, Ohio, United States, 43614
        • Completed
        • University of Toledo Medical Center ( Site 1070)
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Recruiting
        • Oregon Health Science University ( Site 1054)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-494-8311
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212-4737
        • Recruiting
        • Allegheny General Hospital ( Site 1088)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-359-8420
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute for Medical Research ( Site 1089)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-645-2494
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Recruiting
        • Rhode Island Hospital ( Site 1033)
        • Contact:
          • Study Coordinator
          • Phone Number: 401-444-0369
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0001
        • Recruiting
        • Medical University of South Carolina - PPDS ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-3162
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • Statcare Pulmonary Consultants - Knoxville ( Site 1031)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-924-9800
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center ( Site 1079)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-507-3747
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Heart and Vascular Institute ( Site 1078)
        • Contact:
          • Study Coordinator
          • Phone Number: 703-776-3610
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours St. Mary's Hospital ( Site 1069)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-591-3533
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University ( Site 1081)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St Luke's Medical Center ( Site 1083)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-649-3780
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-955-0500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet the following criteria to be enrolled in this proof-of-concept study:

  1. Age 18 to 85 years

  2. Clinical diagnosis of HFpEF:

    • Left ventricular ejection fraction ≥50%, with no history of LVEF below 45% in more than two consecutive measurements under stable conditions

  3. Demonstrated Cpc-PH by all of the following:

    • Baseline RHC performed within 28 days of randomization documenting a minimum PVR of ≥320 dyn•sec/cm5 (4 wood units)
    • Mean pulmonary arterial pressure (mPAP) of >20 mmHg
    • Pulmonary capillary wedge pressure (PCWP) >15 mmHg but < 30 mmHg
  4. New York Heart Association FC of II or III
  5. Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
  6. Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary.

  7. Women of childbearing potential must:

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

  8. 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
  9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements
  10. Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study
  11. Ability to understand and provide documented consent for participation

Exclusion Criteria:

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

  1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5

  2. Documented significant lung disease:

    • Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) <60% predicted
    • Restrictive lung disease with total lung capacity <70% predicted
    • More than mild interstitial lung disease (ILD), with FVC<70% or FEV1<60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging)

  3. Cardiovascular co-morbidities, which include any of the following:

    • History of more than mild mitral or aortic stenosis
    • Ongoing more than mild mitral or aortic regurgitation
    • More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair
    • Severe tricuspid regurgitation due to primary valvular disease
    • Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1
    • History of serious life-threatening or hemodynamically significant arrhythmia
    • History of or anticipated heart transplant or ventricular assist device implantation
    • History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening
    • Anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening or history of implantable cardioverter defibrillator placement
    • Occurrence of myocardial infarction within 180 days of Visit 1
    • History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy
    • Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >110 mmHg during Screening after a period of rest
    • Systemic hypotension as evidenced by sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <50 mmHg during Screening
    • Resting heart rate of <45 bpm or >115 bpm
    • Stroke within 90 days of Visit 1
    • Acutely decompensated HF that required hospitalization within 30 days of Visit 1
    • Electrocardiogram during Screening Period with Fridericia's corrected QT interval (QTcF) >470 msec for males or >480 msec for females, or >500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present
    • Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest
    • Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc
    • Arrhythmogenic right ventricular dysplasia (ARVD) unless the participant has a recent cardiac MRI that shows no evidence of this diagnosis
  4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1
  5. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1
  6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin,or levosimendan) within 30 days of Visit 1
  7. Received erythropoietin within 6 months of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure.
  8. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy)
  9. Prior exposure to sotatercept or luspatercept
  10. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented consent
  11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of Visit 1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)

  12. Any of the following clinical laboratory values prior to Visit 1 as specified:

    • Hemoglobin (Hgb) above the gender-specific upper limit of normal (ULN) per local laboratory test within 28 days of Visit 1or <10 g/dL per local laboratory within 28 days of Visit 1
    • Serum alanine aminotransferase or aspartate aminotransferase levels >3× ULN or total bilirubin >3× ULN within 28 days of Visit 1
    • Estimated glomerular filtration rate <30 ml/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Visit 1 or required renal replacement therapy within 90 days of Visit 1
    • Glycated hemoglobin (HbA1c) >10% within 28 days of Visit 1
    • Platelet count < 75,000/mm3 within 28 days of Visit 1
  13. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product
  14. Major surgery within 60 days of Visit 1. Participants must have completely recovered from any previous surgery prior to Visit 1
  15. Prior heart-lung transplants or life expectancy of <12 months
  16. Pregnancy or breastfeeding in females
  17. History of active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤ 2 squamous cell carcinomas of the skin
  18. History of clinically significant (as determined by the investigator) endocrine, hematologic, hepatic, (auto)immune, infectious (requiring chronic antibiotics), metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study
  19. Body mass index ≥50 kg/m2
  20. Untreated or more than mild obstructive sleep apnea
  21. Any non-cardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits the ability to perform 6-minute walk test (6MWT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, placebo participants will enter into 1 of the 2 sotatercept dose groups in an extension period.
Drug: Placebo
Administered by subcutaneous injection
Experimental: Sotatercept 0.3 mg/kg
Participants will receive sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, participants will continue to receive sotatercept SC at a dose level of 0.3 mg/kg Q3W in an extension period for up to 18 months.
Drug: Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. 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 Names:
  • ACE-011
Experimental: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg
Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period.
Drug: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. 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 Names:
  • ACE-011
Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg
After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a dose of 0.3 mg/kg Q3W for up to 18 months in an extension period.
Drug: Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. 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 Names:
  • ACE-011
Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg
After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and then Q3W for up to 18 months in an extension period.
Drug: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. 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 Names:
  • ACE-011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Time Frame: Baseline and Week 24
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC).
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24
Time Frame: Baseline and Week 24
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
Baseline and Week 24
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 24
Time Frame: Baseline and Week 24
mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization.
Baseline and Week 24
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 24
Time Frame: Baseline and Week 24
PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization.
Baseline and Week 24
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 24
Time Frame: Baseline and Week 24
TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function.
Baseline and Week 24
Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 24
Time Frame: Baseline and Week 24
RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function.
Baseline and Week 24
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24
Time Frame: Baseline and Week 24
LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function.
Baseline and Week 24
Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24
Time Frame: Baseline and Week 24
IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction.
Baseline and Week 24
Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 24
Time Frame: Baseline and Week 24
E/A is a ratio measured in echocardiography as an indicator of diastolic function.
Baseline and Week 24
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24
Time Frame: Baseline and Week 24
NT-proBNP is a circulating biomarker that reflects myocardial stretch.
Baseline and Week 24
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 24
Time Frame: Baseline and Week 24
NYHA FC classifies the extent of heart failure.
Baseline and Week 24
Change From Baseline in Dyspnea Score As Assessed by Borg Category Ratio 10 Scale® at Week 24
Time Frame: Baseline and Week 24
The Borg Category Ratio 10 Scale assesses the severity of shortness of breath as perceived by the participant. The scale is from 0-10 with a higher number indicating more severe dyspnea.
Baseline and Week 24
Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 24
Time Frame: Baseline and Week 24
MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function.
Baseline and Week 24
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48
Time Frame: Baseline and Week 48
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
Baseline and Week 48
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48
Time Frame: Baseline and Week 48
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
Baseline and Week 48
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 48
Time Frame: Baseline and Week 48
mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization.
Baseline and Week 48
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 48
Time Frame: Baseline and Week 48
PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization.
Baseline and Week 48
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 48
Time Frame: Baseline and Week 48
TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function.
Baseline and Week 48
Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 48
Time Frame: Baseline and Week 48
RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function.
Baseline and Week 48
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 48
Time Frame: Baseline and Week 48
LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function.
Baseline and Week 48
Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 48
Time Frame: Baseline and Week 48
IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction.
Baseline and Week 48
Change From Baseline in E/e' (Early Mitral Inflow Velocity E and Mitral Annular Early Diastolic Velocity e') Ratio at Week 48
Time Frame: Baseline and Week 48
E/e' is a ratio measured in echocardiography as an indicator of diastolic function.
Baseline and Week 48
Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 48
Time Frame: Baseline and Week 48
E/A is a ratio measured in echocardiography as an indicator of diastolic function.
Baseline and Week 48
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48
Time Frame: Baseline and Week 48
NT-proBNP is a circulating biomarker that reflects myocardial stretch.
Baseline and Week 48
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48
Time Frame: Baseline and Week 48
NYHA FC classifies the extent of heart failure.
Baseline and Week 48
Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 48
Time Frame: Baseline and Week 48
MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function.
Baseline and Week 48
Change From Baseline in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period
Time Frame: Baseline and Week 48 of the Extension Period
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
Baseline and Week 48 of the Extension Period
Change From Baseline in the 6-minute walk distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period
Time Frame: Baseline and Week 48 of the Extension Period
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
Baseline and Week 48 of the Extension Period
Change From Baseline in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period
Time Frame: Baseline and Week 48 of the Extension Period
NYHA FC classifies the extent of heart failure.
Baseline and Week 48 of the Extension Period
Change in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period
Time Frame: From Week 24 to Week 48 of the Extension Period
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
From Week 24 to Week 48 of the Extension Period
Change in 6-minute Walk Distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period
Time Frame: From Week 24 to Week 48 of the Extension Period
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
From Week 24 to Week 48 of the Extension Period
Change in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period
Time Frame: From Week 24 to Week 48 of the Extension Period
NYHA FC classifies the extent of heart failure.
From Week 24 to Week 48 of the Extension Period
Time to First Clinical Worsening Event (TTCW) at Weeks 24
Time Frame: Week 24

Clinical Worsening events are defined as the number of weeks from first dose date to any of the following:

  • Hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to Pulmonary Hypertension and/or Heart Failure)
  • Administration of intravenous diuretics or subcutaneous (SC) furosemide
  • Death (all causes)
  • Decrease in 6 minute walk distance (6MWD) by ≥ 15% from baseline confirmed by 2 tests at least 4 hours, but no more than 1 week apart.
Week 24
Change From Baseline in ratio of mitral inflow velocity I to mitral annular velocity'(e') (E/e' ratio) at Week 24
Time Frame: Baseline and Week 24
E/e' is a ratio measured in echocardiography as an indicator of diastolic function.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7962-007
  • A011-16 (Other Identifier: Acceleronpharma)
  • MK-7962-007 (Other Identifier: Merck)
  • 2021-003020-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension, Pulmonary

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe