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 (NCT01338415) involved children with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries leading to the lungs is abnormally high. A total of 64 children took part in the main study periods: 33 were given a medicine called bosentan twice a day, and 31 were given bosentan three times a day. A small separate group of 10 participants went through an additional "exceptional use" period. The trial tracked adverse events (any unwanted health occurrences, whether or not thought to be related to the medicine), as well as changes in how severely the condition affected the children over time. The reported data shows that when it came to adverse events — the primary thing being measured — 29 out of 33 children in the twice-daily group and 26 out of 31 children in the three-times-daily group experienced at least one adverse event during the study. For changes in disease severity (rated on a standard scale from Class I, least severe, to Class IV, most severe) at 12 months, the reported data shows that in the twice-daily group, 7 children improved, 4 worsened, and 22 stayed the same; in the three-times-daily group, 3 improved, 3 worsened, and 25 stayed the same. Similar figures were reported at 18 months. Regarding PAH worsening events (such as hospitalisation, death, or needing new treatment), 10 children in the twice-daily group and 5 in the three-times-daily group experienced at least one such event, while 23 and 26 children respectively did not. 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 ↗
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 completed the previous related study (called FUTURE 3 / AC-052-373), or left that study early because your pulmonary arterial hypertension (PAH) got worse — as long as the study medication (bosentan) was not stopped permanently.
- You tolerated the children's form of bosentan well, and the doctors felt bosentan was still helping you at the end of the FUTURE 3 study.
- A parent or legal guardian has signed a consent form before any study procedures begin.
Who may not be able to join:
- You have a known allergy or bad reaction to bosentan or any of its ingredients.
- You have any significant abnormal blood test results that would make it unsafe to continue taking bosentan.
- You are pregnant.
- Your liver enzyme levels (AST and/or ALT) are more than 3 times higher than the normal range, which may indicate a liver problem.
- You have moderate or severe liver disease (confirm with trial site).
- You permanently stopped taking the study medication during the earlier FUTURE 3 study.
- You had a major violation of the rules of the earlier FUTURE 3 study (confirm with trial site).
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.