ACTIVE_NOT_RECRUITING

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

Conditions

Pulmonary Hypertension Chronic Obstructive Pulmonary Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-03-16

Study Completion:2029-10-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05612035

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.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH). * Has non-COPD related Group 3 PH. * Has evidence of untreated more than mild obstructive sleep apnea. * Has significant left heart disease. * Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period. * Has evidence of a resting oxygen saturation (SpO2) \< 88%. * Has experienced a moderate or severe COPD exacerbation within 2 months before randomization. * Has experienced right heart failure within 2 months before randomization. * Has uncontrolled tachyarrhythmia. * Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization. * Has evidence of significant chronic renal insufficiency. * Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities. * Initiated a pulmonary rehabilitation program within 2 months before randomization. * Has impairments that limit the ability to perform 6MWT. * Has history of cancer. * Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence. * Has used PAH-specific therapies within 2 months of randomization.

Inclusion Criteria

Exclusion Criteria

* 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.

* Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).
* Has non-COPD related Group 3 PH.
* Has evidence of untreated more than mild obstructive sleep apnea.
* Has significant left heart disease.
* Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.
* Has evidence of a resting oxygen saturation (SpO2) \< 88%.
* Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.
* Has experienced right heart failure within 2 months before randomization.
* Has uncontrolled tachyarrhythmia.
* Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.
* Has evidence of significant chronic renal insufficiency.
* Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.
* Initiated a pulmonary rehabilitation program within 2 months before randomization.
* Has impairments that limit the ability to perform 6MWT.
* Has history of cancer.
* Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.
* Has used PAH-specific therapies within 2 months of randomization.

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

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

San Francisco, California, 94143

United States

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

Aurora, Colorado, 80045

United States

Clinovation Intl. Corp. ( Site 0108)

Sebring, Florida, 33870

United States

Alexian Brothers Medical Center-Pulmonary ( Site 0109)

Elk Grove Village, Illinois, 60007

United States

University of Iowa ( Site 0103)

Iowa City, Iowa, 52242

United States

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

Kansas City, Kansas, 66160

United States

Lexington VA Medical Center - Cooper Division ( Site 0137)

Lexington, Kentucky, 40502

United States

Corewell Health ( Site 0133)

Grand Rapids, Michigan, 49546

United States

Mayo Clinic in Rochester, Minnesota ( Site 0131)

Rochester, Minnesota, 55905

United States

Creighton University Clinical Research Office ( Site 0123)

Omaha, Nebraska, 68124

United States

University of New Mexico Hospital ( Site 0146)

Albuquerque, New Mexico, 87106

United States

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

Chapel Hill, North Carolina, 27514

United States

Temple University Hospital ( Site 0104)

Philadelphia, Pennsylvania, 19140

United States

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

Pittsburgh, Pennsylvania, 15213

United States

UT Southwestern Medical Center ( Site 0114)

Dallas, Texas, 75390

United States

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

Houston, Texas, 77030

United States

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

Murray, Utah, 84107

United States

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

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

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 Registration Dates

Study Start Date2023-03-16

Study Completion Date2029-10-07

Study Record Updates

Study Start Date2023-03-16

Study Completion Date2029-10-07

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease