Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT02558231) enrolled 247 people with pulmonary arterial hypertension (a condition where blood pressure in the lung arteries is abnormally high). Participants were divided into two groups: 123 people received three medicines together (macitentan, tadalafil, and selexipag), while 124 received two medicines plus a dummy pill (macitentan, tadalafil, and a placebo). The trial ran for 26 weeks and was primarily measuring changes in pulmonary vascular resistance — that is, how much resistance the heart faces when pumping blood through the lung arteries, measured by a procedure called a right heart catheterisation. By the end of the study, 98 participants in each group had completed the trial. The reported data shows that for the main measurement — resistance in the lung arteries — both groups recorded a ratio of less than 1 compared to their starting point, meaning resistance was lower at week 26 than at the beginning. The triple-medicine group recorded a ratio of 0.46 and the double-medicine group recorded 0.48 (where a lower number means a greater reduction from the starting level). For the secondary measurements, the reported data shows that both groups also walked further in a standard six-minute walk test compared to their starting point (an increase of roughly 55 metres in the triple group and 56 metres in the double group). A blood marker linked to heart strain (NT-proBNP) showed a ratio of 0.26 in the triple group and 0.25 in the double group — again, below 1, meaning levels were lower than at the start. Blood pressure in the lung arteries dropped by about 13 mmHg in the triple group and 12 mmHg in the double group, and pressure in the right atrium of the heart dropped by roughly 1.8 mmHg and 1.7 mmHg respectively. Around 99% of the triple-medicine group and 98% of the double-medicine group showed no worsening of their disease class over the 26 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34593120) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Pulmonary Hypertension Trial, Completed
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:
- You are aged 18 to 75 years old
- You have been diagnosed with pulmonary arterial hypertension (high blood pressure in the lungs) less than 6 months before joining the study
- You have had a specific heart and lung pressure test (called a right heart catheterization) within the past 28 days showing certain pressure and resistance levels in your lungs (confirm with trial site)
- Your PAH is one of these types: idiopathic (no known cause), hereditary, caused by a drug or toxin, or linked to a connective tissue disease, HIV infection, or a congenital heart condition
- You are able to walk at least 50 metres in a 6-minute walk test
- If you are a woman who could become pregnant, you must not currently be pregnant, must use reliable contraception, and must agree to regular pregnancy tests during the study
Who may not be able to join:
- You have previously taken or are currently taking any medication specifically for PAH
- You are enrolled in, or have recently completed (within the last 12 weeks), an exercise-based heart and lung rehabilitation program
- Your body mass index (a measure of body weight relative to height) is over 40
- You have three or more of the following conditions at the same time: a BMI over 30, any type of diabetes, high blood pressure, or a history of heart artery disease (such as angina, a heart attack, significant artery blockage, or bypass/stent surgery)
- You had a heart attack within the last 12 weeks
- You had a stroke within the last 12 weeks
- You have a permanent irregular heart rhythm called atrial fibrillation
- Your resting blood pressure is too low (below 90 mmHg systolic) at the time of screening
- You are currently taking or plan to take certain medications called organic nitrates or doxazosin
- You have significant lung disease shown by certain breathing or gas exchange test results falling below specific levels (confirm with trial site)
- You have, or are suspected to have, a rare lung condition called pulmonary veno-occlusive disease
- You have serious liver problems, including certain abnormal liver blood test results or advanced liver disease (confirm with trial site)
- Your liver enzyme blood test results (AST or ALT) are more than 3 times the normal upper limit
- You have severe kidney problems, based on a specific kidney function measurement
- You are currently on dialysis or planning to start dialysis
- Your blood haemoglobin level (a measure of red blood cells) is below 100 g/L
- You have an uncontrolled thyroid condition (overactive or underactive thyroid)
- You have lost vision in one or both eyes due to a specific condition called non-arteritic ischemic optic neuropathy
- You have taken certain medications that strongly affect how the body processes drugs (specific examples include carbamazepine, rifampin, St. John's wort, ketoconazole, clarithromycin, ritonavir, and gemfibrozil) within the past 28 days (confirm with trial site)
- You have taken part in another clinical drug trial within the last 12 weeks, or plan to do so
- You have a known allergy or sensitivity to any of the study medications or their ingredients
- You are pregnant, breastfeeding, or planning to become pregnant during the study
- You have another serious illness where life expectancy is less than 12 months
- You have a problem with alcohol use
- There is any other reason the trial doctor believes you may have difficulty following the study requirements
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
Australian sites
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline to Week 26 in Pulmonary Vascular Resistance (PVR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.