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

Status: Active_not_recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.

• Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.

• Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.

• Has a WHO Functional Class assessment of Class II to IV.

• If on supplemental oxygen, the regimen must be stable.

• Has stable and optimized chronic, baseline COPD-specific therapy.

• If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period.

• If on antihypertensives and/or a diuretic regimen has stable concomitant use.

• If on anticoagulants has stable concomitant use.

• Is of any sex/gender from 40 to 85 years of age inclusive.

• Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.

Locations
United States
California
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)
San Francisco
Colorado
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)
Aurora
Florida
Clinovation Intl. Corp. ( Site 0108)
Sebring
Iowa
University of Iowa ( Site 0103)
Iowa City
Illinois
Alexian Brothers Medical Center-Pulmonary ( Site 0109)
Elk Grove Village
Kansas
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
Kansas City
Kentucky
Lexington VA Medical Center - Cooper Division ( Site 0137)
Lexington
Michigan
Corewell Health ( Site 0133)
Grand Rapids
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 0131)
Rochester
North Carolina
UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147)
Chapel Hill
Nebraska
Creighton University Clinical Research Office ( Site 0123)
Omaha
New Mexico
University of New Mexico Hospital ( Site 0146)
Albuquerque
Pennsylvania
Temple University Hospital ( Site 0104)
Philadelphia
UPMC Montefiore University Hospital-Department of Medicine ( Site 0149)
Pittsburgh
Texas
UT Southwestern Medical Center ( Site 0114)
Dallas
The University of Texas Health Science Center at Houston ( Site 0105)
Houston
Utah
Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)
Murray
Virginia
University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)
Charlottesville
Other Locations
Argentina
Fundación Respirar ( Site 0305)
Caba
Hospital Britanico de Buenos Aires ( Site 0307)
Caba
Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)
Córdoba
Centro Medico Capital ( Site 0301)
La Plata
Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)
San Miguel De Tucumán
Australia
WESLEY RESEARCH INSTITUTE Limited ( Site 0906)
Auchenflower
The Prince Charles Hospital ( Site 0904)
Brisbane
Royal Prince Alfred Hospital-Department of Respiratory Medicine ( Site 0903)
Camperdown
Mater Misericordiae Limited ( Site 0905)
South Brisbane
Westmead Hospital ( Site 0902)
Westmead
Austria
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)
Graz
Medizinische Universitaet Innsbruck ( Site 1202)
Innsbruck
Belgium
Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)
Brussels
UZ Leuven ( Site 1301)
Leuven
Colombia
Ciensalud Ips S A S ( Site 0508)
Barranquilla
Centro de Investigaciones Clinicas SAS ( Site 0505)
Cali
Fundación Valle del Lili ( Site 0509)
Cali
Clinica Cardio VID ( Site 0504)
Medellín
France
CHU Angers ( Site 1506)
Angers
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)
Le Kremlin-bicêtre
C.H.U Hôpital Nord ( Site 1503)
Marseille
Centre Hospitalier Universitaire de Poitiers ( Site 1505)
Poitiers
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502)
Vandœuvre-lès-nancy
Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)
Dresden
UKGM Gießen/Marburg ( Site 1604)
Giessen
Medizinische Hochschule Hannover ( Site 1602)
Hanover
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)
Heidelberg
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)
Lübeck
Guatemala
Clinica Medica ( Site 0601)
Guatemala City
MEDI-K ( Site 0607)
Guatemala City
Private Practice - Dr. Jeremias Guerra Mejia ( Site 0603)
Guatemala City
Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605)
Guatemala City
Israel
Rambam Health Care Campus ( Site 1701)
Haifa
Rabin Medical Center ( Site 1702)
Petah Tikva
Italy
Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)
Monza
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)
Palermo
Cattinara Hospital ( Site 1801)
Trieste
Mexico
INVECORDIS S.C. ( Site 0703)
Hacienda De Las Palmas
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)
México
Centro Médico Nacional Siglo XXI ( Site 0708)
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0704)
Mexico City
Peru
Unidad de Investigacon de la Clinica Internacional ( Site 0804)
Lima Cercado
Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806)
San Isidro
Clínica Providencia ( Site 0803)
San Miguel
Republic of Korea
Gachon University Gil Medical Center ( Site 1101)
Namdong-gu
Asan Medical Center ( Site 1102)
Seoul
Samsung Medical Center ( Site 1104)
Seoul
Seoul National University Hospital ( Site 1103)
Seoul
South Africa
TREAD Research ( Site 2101)
Cape Town
Netcare St Augustine's Hospital ( Site 2105)
Durban
Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108)
Johannesburg
Netcare Milpark Hospital ( Site 2103)
Johannesburg
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)
Barcelona
Hospital Universitari Vall d'Hebron ( Site 2002)
Barcelona
Parc de Salut Mar - Hospital del Mar ( Site 2006)
Barcelona
Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)
Santander
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)
Seville
Switzerland
University Hospital Basel ( Site 2205)
Basel
Cantonal Hospital St.Gallen ( Site 2203)
Sankt Gallen
UniversitätsSpital Zürich ( Site 2201)
Zurich
Turkey
Ankara Bilkent Şehir Hastanesi. ( Site 2307)
Ankara
Hacettepe Universite Hastaneleri ( Site 2301)
Ankara
Eskisehir Osmangazi University-Cardiology ( Site 2304)
Eskişehir
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302)
Istanbul
United Kingdom
Hammersmith Hospital-Department of Cardiology ( Site 2401)
London
Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)
Sheffield
Time Frame
Start Date: 2023-03-16
Completion Date: 2029-10-07
Participants
Target number of participants: 120
Treatments
Experimental: Frespaciguat
Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).
Placebo_comparator: Placebo
Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov