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:

• People who were first diagnosed with pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) less than 6 months before joining the trial
• People whose test results showed that their blood vessels in the lungs did not respond to vasodilator (vessel-widening) medication during a specific lung pressure test (confirm with trial site)
• People who have not previously received any treatment specifically for pulmonary arterial hypertension, and whose condition falls into one of these categories: no known cause, inherited, caused by a drug or toxin, related to a connective tissue disease, related to HIV infection, or related to a heart defect that was surgically corrected more than one year ago
• People whose heart and lung pressure measurements — taken through a procedure that measures blood flow through the heart — meet all three of the following: average lung artery pressure of 25 mmHg or higher, heart filling pressure below 15 mmHg, and lung vascular resistance of 3 units or higher (confirm with trial site)
• People who have at least two of the following health conditions: a history of high blood pressure, diabetes (any type), obesity (body mass index of 30 or above), or established coronary heart disease (including past heart attack, past heart procedures, significant narrowing of heart arteries, or stable chest pain)
• People who are able to understand the study procedures
• Women who could become pregnant must be using an effective form of contraception from the screening visit until one month after stopping the last study treatment
• People who are enrolled in the French social security system
• People who have given their written informed consent to participate

Who may not be able to join:

• People whose pulmonary hypertension is linked to liver disease (a condition called porto-pulmonary hypertension)
• People who have an uncorrected heart defect that causes blood to flow abnormally between the heart's chambers or major vessels
• People who have evidence of blood clots in the lungs, as detected by specific lung imaging tests
• People who are already on a waiting list for a lung or heart-lung transplant at the time of screening
• People who have taken any medication specifically for pulmonary arterial hypertension at any point before joining the trial
• People with known moderate to severe lung disease that restricts breathing, causes airflow obstruction, or has been identified through chest imaging (such as scarring of the lungs or emphysema)
• People with a known or suspected condition where the small veins in the lungs become blocked (pulmonary veno-occlusive disease)
• People with severely reduced kidney function (confirm with trial site)
• People with documented severe liver impairment, including certain abnormal liver blood test results or advanced liver disease classified as Child-Pugh Class C (confirm with trial site)
• People with a low red blood cell level (haemoglobin below 10 g/dL)
• People who are under legal guardianship, a protective supervision order, or who are deprived of their liberty
• People who are pregnant or breastfeeding
• People currently using another medication in the same drug class (PDE-5 inhibitors) for erectile dysfunction
• People who are currently taking or planning to take nitrate medications or a medication called doxazosin
• People who are currently taking or planning to take a medication called riociguat
• People who have taken certain strong medications that affect how the body processes drugs (including carbamazepine, rifampin, rifampicin, rifabutin, rifapentine, phenobarbital, phenytoin, or St. John's Wort) within 28 days before joining the trial

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