Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with a specific type of pulmonary arterial hypertension (high blood pressure in the lungs) classified as WHO Category I
• Testing of your heart (via a procedure called right heart catheterization) has shown that the pressure in your pulmonary artery is high and that the pressure on the left side of your heart is normal
• A pulmonary hypertension specialist has decided you need a specific medication given through a vein or under the skin (parenteral treprostinil)

Who may not be able to join:

• Your general blood pressure is very low (below 60 mmHg) or you need medications to keep your blood pressure up
• Your doctors expect you will soon need a heart-lung support machine (such as ECMO or a right heart assist device) or a lung transplant within the next 3 months
• Your heart's left pumping chamber is not working well enough, or you have heart failure of a certain type, or you have moderate-to-severe problems with your aortic or mitral heart valves
• You have severe lung disease that significantly limits how much air you can breathe in or out (confirm with trial site)
• You have had a blood clot in your lungs (pulmonary embolism) in the last 3 months, or you have evidence of long-term blood clots in your lungs
• You have a medical reason why you cannot safely have a right heart catheterization procedure
• You have taken any medications that affect the blood vessels in your lungs in the last 12 weeks
• Your pulmonary hypertension involves the veins or small blood vessels of the lungs in a specific way, or you have certain related rare lung conditions (confirm with trial site)
• Your pulmonary hypertension belongs to WHO groups 2 through 5 (meaning it is caused by other conditions such as heart disease, lung disease, blood clots, or other disorders)
• You have moderate or severe liver disease (classified as Child-Pugh Class B or C)
• Your kidneys are not working well enough (kidney filtration rate below 30 mL/min)
• Certain liver enzyme levels in your blood (AST and/or ALT) are too high
• Your hemoglobin (a measure of red blood cells) is significantly below the normal range
• You have a physical condition (other than breathlessness) that would make it hard to take part in the study
• You are currently pregnant or breastfeeding
• If you are a woman who could become pregnant, you are not willing or able to either avoid sexual intercourse or use two reliable forms of contraception during the study and for at least 30 days after finishing the study medication
• You have another serious illness where doctors expect you may not survive beyond 12 months
• Your body weight is below 40 kg (about 88 lbs) or above 150 kg (about 330 lbs)
• You have any other condition that would make it difficult to follow the study rules or take the medication as required
• You are currently taking certain medications that could interact with the study drugs, including some antifungal, antibiotic, or HIV medications, or theophylline (confirm full list with trial site)
• You have taken any nitrate medications (such as those used for chest pain) within the 4 weeks before joining the study
• You have a known allergy or sensitivity to medications in the same family as the study drugs
• You have been treated with, or are planned to receive, another experimental drug within 1 month before joining the study
• You have coughed up blood in the last 6 months, or have a history of severe episodes of coughing up blood that needed a medical procedure to stop it

Important: Always verify eligibility with the trial site directly before applying.