A Phase 2a Study to Evaluate the Safety and Efficacy of MK-5475 in Adults With Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease

Phase 1

Recruiting

• Conditions: Pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).; MedDRA version: 21.1Level: LLTClassification code: 10037403Term: Pulmonary hypertension NOS Class: 10038738; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2022-501201-13-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

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

Exclusion Criteria

Has history of Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH), 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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified