Last updated 13 days ago
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD
120 patients around the world
Available in Spain, Colombia, United States, Argentina
Merck Sharp & Dohme LLC
5Research sites
120Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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 evidence 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.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 history of Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).Has history of 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.
Sites
Centro Médico Capital
Recruiting
Fundación Respirar
Recruiting
Fundación Valle del Lili
Recruiting
Clínica Cardiovascular Santa María
Recruiting
Ciensalud Ips S A S
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Copd
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05612035
