Phase 3 Pulmonary Hypertension Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have signed a consent form (or had their legal representative sign one) showing they understand the study and are willing to take part.
- People who were taking oral macitentan, selexipag, or a fixed-dose combination of macitentan 10mg and tadalafil 40mg at the end of a related "parent" study for pulmonary arterial hypertension (a type of high blood pressure affecting the lungs), who completed that parent study, who may still benefit from the treatment, and for whom no other way of accessing the same or equivalent approved treatment has been identified.
- People who are at least 18 years old if taking the macitentan/tadalafil combination, or at least 2 years old if taking macitentan or selexipag alone.
- Women of childbearing age who test negative for pregnancy before starting, agree to monthly pregnancy tests during the study, and agree to use contraception for at least 30 days after the last dose if they are sexually active with a male partner.
Who may not be able to join:
- People who stopped taking their study medication early (before completing their parent study).
- Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
- People who are currently taking, or plan to take, another experimental treatment.
- People with a known allergy or intolerance to macitentan or tadalafil (depending on which medication is being used in this study).
- People with a known allergy or intolerance to selexipag (if that is the medication being used).
- People whose red blood cell levels (haemoglobin) are too low — below 80 g/L for macitentan or the combination tablet, or below 75% of the normal lower limit for children taking selexipag.
- People with certain liver enzyme levels that are more than 3 times the upper limit of the normal range (applies to macitentan and the combination tablet).
- People with severe liver disease (known as Child-Pugh Class C).
- People taking selexipag who have a lung condition called pulmonary veno-occlusive disease (a blockage of veins in the lungs).
- People taking selexipag who have an uncontrolled thyroid condition.
- People taking selexipag who have had a heart attack in the last 6 months, a stroke or mini-stroke in the last 3 months, severe coronary heart disease, unstable chest pain, uncontrolled heart failure, severe irregular heart rhythm, or certain heart valve problems unrelated to their lung condition.
- Children taking selexipag where there is any concern about a bowel blockage or related condition (confirm with trial site).
- People taking the macitentan/tadalafil combination who have severely reduced kidney function (a filtration rate below 30 mL/min).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Actelion Pharmaceuticals Ltd Clinical Trial, Actelion
Phone: 844-434-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Frequency of Treatment Emergent Adverse Events (TEAEs); Frequency of TEAEs Leading to Discontinuation; Frequency of Serious Adverse Events (SAEs); Frequency of Deaths
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.