NCT06009185

Who might be able to join this trial:

• You must have completed a specific visit (called "MPV3") in the earlier related study called BIA-51058-201.
• You must be able to understand and be willing to sign a consent form agreeing to take part.
• If you are a woman: you must agree not to donate eggs from the time you sign the consent form until 30 days after taking your last dose of the study medicine.
• If you are a man: you must agree not to donate sperm from the time you sign the consent form until 90 days after taking your last dose of the study medicine.

Who may not be able to join:

• You did not follow the rules of the earlier study BIA-51058-201 in a way that could affect this study.
• Your doctor judges your heart/lung condition to be at the most severe level (WHO functional class IV).
• Your blood pressure was too low (below certain levels) on two or more readings at your first visit.
• You have poorly controlled diabetes, based on a blood sugar measurement called HbA1c being 8.5% or higher in the last three months or at your first visit.
• You had a side effect during the earlier study that your doctor believes makes it unsafe for you to continue.
• You have a cause of high blood pressure in the lungs (pulmonary hypertension) other than the specific type this study is investigating (PAH WHO Group 1).
• You have a certain type of lung disease that blocks airflow (obstructive lung disease), based on previous breathing test results (confirm with trial site).
• You have a certain type of lung disease that restricts lung size (restrictive lung disease), based on previous breathing test results (confirm with trial site).
• You have a history of moderate or severe liver problems (known as Child-Pugh B or C).
• Your kidneys are not working well enough, based on a specific kidney function measurement taken during the earlier study (confirm with trial site).
• You are taking or plan to take certain medicines that are not allowed in this study, including some blood pressure medicines (calcium channel blockers used for PAH in certain patients), certain heart/circulation medicines (such as isoprenaline, dopamine, or dobutamine), or medicines that block certain signals in your body (alpha- or beta-blockers).
• You have another serious or worsening health condition that your doctor believes could affect the study results or put your safety at risk.
• If you are a woman: you are pregnant or breastfeeding, or you are unwilling or unable to take regular pregnancy tests and use a highly effective form of contraception combined with a barrier method (such as a condom) from consent until 30 days after your last dose. Note: certain methods such as hormonal contraceptives alone, the rhythm method, or withdrawal are not accepted (confirm with trial site for full details).
• If you are a man: if you are sexually active with a partner who could become pregnant, you and your partner must use a condom plus an additional approved contraceptive method from consent until 90 days after your last dose (confirm with trial site for full details).
• You are currently taking part in any other drug research study, except for the earlier related study BIA-51058-201.
• You are considered a "vulnerable patient" under international guidelines for good clinical practice (confirm with trial site).

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