Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from the 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 (PAH) — a condition causing high blood pressure in the lungs — classified as idiopathic, heritable, caused by a drug or toxin, related to a connective tissue disease, or related to a congenital heart defect that was repaired at least 1 year ago.
• You have had your PAH diagnosis for at least 3 months before the screening visit.
• Your PAH symptoms fall within a moderate-to-severe range based on a standard breathing and activity scale (functional class II, III, or IV).
• You are already taking 1 to 3 approved PAH medications (from specific drug classes) at a stable dose — most for at least 3 months, or at least 6 months if one of them is sotatercept (confirm with trial site for exact medication requirements).
• If you are taking sotatercept, you must have had no significant bleeding episodes in the past 3–6 months and have a healthy platelet count (confirm with trial site).
• On two walking tests, you are able to walk between 150 and 450 metres in 6 minutes.
• You have had a specific heart procedure called a right heart catheterization (a test measuring blood pressure inside the lungs) — either at screening or within the 6 months before — showing results that meet specific pressure measurements (confirm with trial site).

Who may not be able to join:

• You have a different type of pulmonary hypertension (not WHO Group 1 PAH), or your PAH is linked to HIV, complex congenital heart disease, liver-related high blood pressure, or certain other specific causes.
• You have significant heart problems on the left side of your heart, such as valve disease, poor heart pumping, unstable chest pain, or irregular heartbeat.
• You have evidence of significant airflow blockage in your lungs, as shown by breathing tests.
• You have a significantly reduced lung capacity, as shown by breathing tests.
• You have a history of chronic blood clots in the lungs, or had an acute blood clot in the lungs within the past 6 months.
• You have a known allergy or medical reason to avoid the study drug (treprostinil or TPIP) or any of its ingredients (such as mannitol or leucine).
• You have any other medical or mental health condition that, in the doctor's opinion, could put you at unreasonable risk, affect your ability to complete the trial, or make the results harder to interpret (confirm with trial site).

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