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A Study of the Efficacy and Safety of MK-5475 in Participants with Pulmonary Arterial Hypertension
EU CTIS ID: 2022-500877-15-00
What this study is testing
1. To evaluate the effect of MK-5475 versus placebo on the pulmonary vascular resistance (PVR) at Week 12 in the Phase 2 Cohort 2. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 12 in the Phase 3 Cohort
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pulmonary arterial hypertension (PAH) in one of the following groups: Idiopathic PAH, heritable PAH, drug and toxin-induced PAH, PAH associated with connective tissue disease, HIV infection, or congenital heart disease
- Diagnosis of PAH documented by right heart catheterization (RHC).
- Eligibility RHC meeting all of the following criteria: Mean pulmonary artery pressure (mPAP) ≥25 mmHg, pulmonary vascular resistance (PVR) of ≥3 Wood units, and pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg.
- World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
- Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization.
- Stable concomitant background PAH-specific therapy.
You likely can't join if
- Group 2 to 5 pulmonary hypertension
- Current smoker or currently uses electronic cigarettes (vapes).
- History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.
- PAH in one of the following groups: Long term responders to calcium channel blockers, or overt features of venous/capillary involvement
- Evidence of more-than-mild obstructive lung disease or parenchymal lung disease.
- Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated.
See the full eligibility criteria
- Pulmonary arterial hypertension (PAH) in one of the following groups: Idiopathic PAH, heritable PAH, drug and toxin-induced PAH, PAH associated with connective tissue disease, HIV infection, or congenital heart disease
- Diagnosis of PAH documented by right heart catheterization (RHC).
- Eligibility RHC meeting all of the following criteria: Mean pulmonary artery pressure (mPAP) ≥25 mmHg, pulmonary vascular resistance (PVR) of ≥3 Wood units, and pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg.
- World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
- Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization.
- Stable concomitant background PAH-specific therapy.
- Body Mass Index (BMI) between 18.5 kg/m² and 40 kg/m².
- Group 2 to 5 pulmonary hypertension
- Current smoker or currently uses electronic cigarettes (vapes).
- History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.
- PAH in one of the following groups: Long term responders to calcium channel blockers, or overt features of venous/capillary involvement
- Evidence of more-than-mild obstructive lung disease or parenchymal lung disease.
- Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated.
- Evidence or history of left heart disease, including any of the following: Left ventricular ejection fraction (LVEF) ≤45%, moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation), or significant left ventricular diastolic dysfunction on echocardiographic evaluation.
- Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI>30 kg/m², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease.
- Oxygen saturation measured by pulse oximetry (SpO₂) <90%, despite supplemental oxygen therapy.
- Chronic renal insufficiency (eGFR <30 mL/min)
- Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Mexico
- Australia
- Canada
- United Kingdom
- New Zealand
- Israel
- Russian Federation
- Turkey
- Argentina
- Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Mexico; Australia; Canada; United Kingdom; New Zealand and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.