Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 16, 2023

Primary Completion Date

April 7, 2026

Study Completion Date

October 7, 2029

Conditions
Pulmonary HypertensionChronic Obstructive Pulmonary Disease
Interventions
DRUG

Frespaciguat

Frespaciguat 380 µg administered as dry powder inhalation once daily.

DRUG

Placebo

Placebo administered as dry powder inhalation once daily.

Trial Locations (84)

1070

Université Libre de Bruxelles - Hôpital Erasme ( Site 1302), Brussels

1904

Centro Medico Capital ( Site 0301), La Plata

2050

Royal Prince Alfred Hospital-Department of Respiratory Medicine ( Site 0903), Camperdown

2145

Westmead Hospital ( Site 0902), Westmead

2193

Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108), Johannesburg

Netcare Milpark Hospital ( Site 2103), Johannesburg

3000

UZ Leuven ( Site 1301), Leuven

4000

Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303), San Miguel de Tucumán

4001

Netcare St Augustine's Hospital ( Site 2105), Durban

4031

University Hospital Basel ( Site 2205), Basel

4032

The Prince Charles Hospital ( Site 0904), Brisbane

4066

WESLEY RESEARCH INSTITUTE Limited ( Site 0906), Auchenflower

4101

Mater Misericordiae Limited ( Site 0905), South Brisbane

6020

Medizinische Universitaet Innsbruck ( Site 1202), Innsbruck

7500

TREAD Research ( Site 2101), Cape Town

8036

Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201), Graz

8091

UniversitätsSpital Zürich ( Site 2201), Zurich

9007

Cantonal Hospital St.Gallen ( Site 2203), Sankt Gallen

13915

C.H.U Hôpital Nord ( Site 1503), Marseille

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0704), Mexico City

Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701), México

15001

Unidad de Investigacon de la Clinica Internacional ( Site 0804), Lima Cercado

15036

Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806), San Isidro

15088

Clínica Providencia ( Site 0803), San Miguel

15213

UPMC Montefiore University Hospital-Department of Medicine ( Site 0149), Pittsburgh

19140

Temple University Hospital ( Site 0104), Philadelphia

20900

Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802), Monza

21565

Gachon University Gil Medical Center ( Site 1101), Namdong-gu

22908

University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111), Charlottesville

23538

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605), Lübeck

26480

Eskisehir Osmangazi University-Cardiology ( Site 2304), Eskişehir

27514

UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147), Chapel Hill

30625

Medizinische Hochschule Hannover ( Site 1602), Hanover

33870

Clinovation Intl. Corp. ( Site 0108), Sebring

34093

Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302), Istanbul

34149

Cattinara Hospital ( Site 1801), Trieste

35392

UKGM Gießen/Marburg ( Site 1604), Giessen

39008

Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003), Santander

40502

Lexington VA Medical Center - Cooper Division ( Site 0137), Lexington

41013

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005), Seville

49546

Corewell Health ( Site 0133), Grand Rapids

49933

CHU Angers ( Site 1506), Angers

52242

University of Iowa ( Site 0103), Iowa City

52787

INVECORDIS S.C. ( Site 0703), Hacienda de Las Palmas

54511

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502), Vandœuvre-lès-Nancy

55905

Mayo Clinic in Rochester, Minnesota ( Site 0131), Rochester

60007

Alexian Brothers Medical Center-Pulmonary ( Site 0109), Elk Grove Village

66160

University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102), Kansas City

68124

Creighton University Clinical Research Office ( Site 0123), Omaha

69126

Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603), Heidelberg

75390

UT Southwestern Medical Center ( Site 0114), Dallas

77030

The University of Texas Health Science Center at Houston ( Site 0105), Houston

80045

University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101), Aurora

84107

Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140), Murray

86021

Centre Hospitalier Universitaire de Poitiers ( Site 1505), Poitiers

87106

University of New Mexico Hospital ( Site 0146), Albuquerque

90127

ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804), Palermo

94143

UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110), San Francisco

94270

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501), Le Kremlin-Bicêtre

760032

Fundación Valle del Lili ( Site 0509), Santiago de Cali

760036

Centro de Investigaciones Clinicas SAS ( Site 0505), Santiago de Cali

3109601

Rambam Health Care Campus ( Site 1701), Haifa

C1426ABP

Fundación Respirar ( Site 0305), CABA

C1280AEB

Hospital Britanico de Buenos Aires ( Site 0307), CABA

X5016KEH

Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302), Córdoba

050034

Clinica Cardio VID ( Site 0504), Medellín

08001

Ciensalud Ips S A S ( Site 0508), Barranquilla

01307

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601), Dresden

01001

Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605), Guatemala City

01009

MEDI-K ( Site 0607), Guatemala City

01010

Clinica Medica ( Site 0601), Guatemala City

Private Practice - Dr. Jeremias Guerra Mejia ( Site 0603), Guatemala City

4941 492

Rabin Medical Center ( Site 1702), Petah Tikva

06760

Centro Médico Nacional Siglo XXI ( Site 0708), Mexico City

03080

Seoul National University Hospital ( Site 1103), Seoul

05505

Asan Medical Center ( Site 1102), Seoul

06355

Samsung Medical Center ( Site 1104), Seoul

08036

HOSPITAL CLÍNIC DE BARCELONA ( Site 2001), Barcelona

08003

Parc de Salut Mar - Hospital del Mar ( Site 2006), Barcelona

08035

Hospital Universitari Vall d'Hebron ( Site 2002), Barcelona

06230

Hacettepe Universite Hastaneleri ( Site 2301), Ankara

06800

Ankara Bilkent Şehir Hastanesi. ( Site 2307), Ankara

W12 OHS

Hammersmith Hospital-Department of Cardiology ( Site 2401), London

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405), Sheffield

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY