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

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05612035Tipo: INTERVENTIONALInicio: 16 de mar de 2023Fin estimado: 7 de oct de 2029

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Frespaciguat

Frespaciguat 380 µg administered as dry powder inhalation once daily.

drug

Placebo

Placebo administered as dry powder inhalation once daily.

Ubicaciones

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

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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