Resumen

Los investigadores buscan formas de tratar la hipertensión pulmonar (HP) causada por la enfermedad pulmonar obstructiva crónica (EPOC). El objetivo del estudio es determinar si las personas que toman frespaciguat pueden caminar más distancia en 6 minutos en la Semana 24 en comparación con las personas que toman 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.

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

Estudio clínico de fase 2a, aleatorizado y controlado con placebo para evaluar la eficacia y seguridad de MK-5475 en adultos con hipertensión pulmonar asociada a enfermedad pulmonar obstructiva crónica