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ACTIVE NOT RECRUITING
NCT05612035
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Official title: A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-03-16

Completion Date

2029-10-07

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Frespaciguat

Frespaciguat 380 µg administered as dry powder inhalation once daily.

DRUG

Placebo

Placebo administered as dry powder inhalation once daily.

Locations (85)

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

San Francisco, California, United States

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

Aurora, Colorado, United States

Clinovation Intl. Corp. ( Site 0108)

Sebring, Florida, United States

Alexian Brothers Medical Center-Pulmonary ( Site 0109)

Elk Grove Village, Illinois, United States

University of Iowa ( Site 0103)

Iowa City, Iowa, United States

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

Kansas City, Kansas, United States

Lexington VA Medical Center - Cooper Division ( Site 0137)

Lexington, Kentucky, United States

Corewell Health ( Site 0133)

Grand Rapids, Michigan, United States

Mayo Clinic in Rochester, Minnesota ( Site 0131)

Rochester, Minnesota, United States

Creighton University Clinical Research Office ( Site 0123)

Omaha, Nebraska, United States

University of New Mexico Hospital ( Site 0146)

Albuquerque, New Mexico, United States

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

Chapel Hill, North Carolina, United States

Temple University Hospital ( Site 0104)

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center ( Site 0114)

Dallas, Texas, United States

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

Houston, Texas, United States

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

Murray, Utah, United States

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

Charlottesville, Virginia, United States

Fundación Respirar ( Site 0305)

CABA, Buenos Aires, Argentina

Centro Medico Capital ( Site 0301)

La Plata, Buenos Aires, Argentina

Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Britanico de Buenos Aires ( Site 0307)

CABA, Argentina

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

Córdoba, Argentina

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

Camperdown, New South Wales, Australia

Westmead Hospital ( Site 0902)

Westmead, New South Wales, Australia

WESLEY RESEARCH INSTITUTE Limited ( Site 0906)

Auchenflower, Queensland, Australia

The Prince Charles Hospital ( Site 0904)

Brisbane, Queensland, Australia

Mater Misericordiae Limited ( Site 0905)

South Brisbane, Queensland, Australia

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

Graz, Styria, Austria

Medizinische Universitaet Innsbruck ( Site 1202)

Innsbruck, Tyrol, Austria

Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)

Brussels, Bruxelles-Capitale, Region de, Belgium

UZ Leuven ( Site 1301)

Leuven, Vlaams-Brabant, Belgium

Clinica Cardio VID ( Site 0504)

Medellín, Antioquia, Colombia

Ciensalud Ips S A S ( Site 0508)

Barranquilla, Atlántico, Colombia

Fundación Valle del Lili ( Site 0509)

Cali, Valle del Cauca Department, Colombia

Centro de Investigaciones Clinicas SAS ( Site 0505)

Cali, Valle del Cauca Department, Colombia

C.H.U Hôpital Nord ( Site 1503)

Marseille, Bouches-du-Rhone, France

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

Vandœuvre-lès-Nancy, Lorraine, France

CHU Angers ( Site 1506)

Angers, Maine-et-Loire, France

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

Le Kremlin-Bicêtre, Paris, France

Centre Hospitalier Universitaire de Poitiers ( Site 1505)

Poitiers, Vienne, France

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

Heidelberg, Baden-Wurttemberg, Germany

UKGM Gießen/Marburg ( Site 1604)

Giessen, Hesse, Germany

Medizinische Hochschule Hannover ( Site 1602)

Hanover, Lower Saxony, Germany

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)

Dresden, Saxony, Germany

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)

Lübeck, Schleswig-Holstein, Germany

Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605)

Guatemala City, Guatemala

MEDI-K ( Site 0607)

Guatemala City, Guatemala

Clinica Medica ( Site 0601)

Guatemala City, Guatemala

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

Guatemala City, Guatemala

Rambam Health Care Campus ( Site 1701)

Haifa, Israel

Rabin Medical Center ( Site 1702)

Petah Tikva, Israel

Cattinara Hospital ( Site 1801)

Trieste, Friuli Venezia Giulia, Italy

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

Monza, Lombardy, Italy

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

Palermo, Italy

Centro Médico Nacional Siglo XXI ( Site 0708)

Mexico City, Mexico City, Mexico

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

Mexico City, Mexico City, Mexico

INVECORDIS S.C. ( Site 0703)

Hacienda de Las Palmas, State of Mexico, Mexico

Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)

México, Mexico

Unidad de Investigacon de la Clinica Internacional ( Site 0804)

Lima Cercado, Lima region, Peru

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

San Isidro, Lima region, Peru

Clínica Providencia ( Site 0803)

San Miguel, Lima region, Peru

Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108)

Johannesburg, Gauteng, South Africa

Netcare Milpark Hospital ( Site 2103)

Johannesburg, Gauteng, South Africa

Netcare St Augustine's Hospital ( Site 2105)

Durban, KwaZulu-Natal, South Africa

TREAD Research ( Site 2101)

Cape Town, Western Cape, South Africa

Gachon University Gil Medical Center ( Site 1101)

Namdong-gu, Incheon, South Korea

Seoul National University Hospital ( Site 1103)

Seoul, South Korea

Asan Medical Center ( Site 1102)

Seoul, South Korea

Samsung Medical Center ( Site 1104)

Seoul, South Korea

Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)

Santander, Cantabria, Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)

Barcelona, Catalonia, Spain

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

Barcelona, Spain

Hospital Universitari Vall d'Hebron ( Site 2002)

Barcelona, Spain

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)

Seville, Spain

University Hospital Basel ( Site 2205)

Basel, Canton of Basel-City, Switzerland

UniversitätsSpital Zürich ( Site 2201)

Zurich, Canton of Zurich, Switzerland

Cantonal Hospital St.Gallen ( Site 2203)

Sankt Gallen, Switzerland

Hacettepe Universite Hastaneleri ( Site 2301)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi. ( Site 2307)

Ankara, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals ( Site 2310)

Ankara, Turkey (Türkiye)

Eskisehir Osmangazi University-Cardiology ( Site 2304)

Eskişehir, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Hammersmith Hospital-Department of Cardiology ( Site 2401)

London, London, City of, United Kingdom

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

Sheffield, United Kingdom