Phase 3 Pulmonary Hypertension Trial, Active, Not Recruiting NCT04175600 Sponsor: Actelion Condition: Pulmonary Hypertension
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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 (NCT04175600) enrolled 138 people with pulmonary arterial hypertension (a condition where blood pressure in the arteries supplying the lungs is abnormally high) — 69 received a placebo (dummy treatment) and 69 received a medicine called selexipag. The trial was primarily measuring how long it took for participants' condition to get worse, defined by specific events such as death, being added to a lung transplant waiting list, being hospitalised due to worsening disease, or other signs of clinical decline. The reported data shows that for the placebo group, the estimated median time to one of those disease progression events was approximately 35.3 months; for the selexipag group, this figure was listed as "not available" (NA) in the submitted data, meaning a median could not be calculated from the reported figures — this was not reported rather than being a missing error. For a secondary measure — a blood marker called NT-proBNP (a protein released when the heart is under strain, where a lower ratio suggests less strain) — the reported ratio of the Week 24 level compared to the starting level was 1.05 in the placebo group and 0.98 in the selexipag group, meaning levels were broadly similar at that time point across both groups. Regarding adverse events (unwanted medical occurrences during the trial), the reported data shows that 65 of 69 placebo participants and 68 of 69 selexipag participants experienced at least one adverse event; serious adverse events were reported in 26 placebo participants and 32 selexipag participants. Thirteen placebo participants and 9 selexipag participants stopped treatment early due to an adverse event. Small changes in blood pressure and pulse rate across various time points were also recorded as secondary measures, with the reported figures varying modestly between the two groups at different time points — the data did not show a consistent or large difference in either direction between the groups for these physical measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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, Active, Not Recruiting

NCT04175600
Active, Not Recruiting Phase 3 🇦🇺 Australian site

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:

  • Children aged 2 years old up to (but not including) 18 years old, who weigh at least 9 kilograms at the time of joining the trial
  • Children who have been diagnosed with pulmonary arterial hypertension (a type of high blood pressure affecting the lungs), confirmed by a specific heart test called a right heart catheterization done at any point before the study screening
  • Children whose lung blood pressure condition falls into one of these categories: no known cause (idiopathic), inherited/genetic, related to a heart defect present at birth (including certain cases — confirm with trial site), developed after surgery to repair a heart defect, caused by a drug or toxin, or related to HIV infection; children with Down syndrome may also be eligible
  • Children whose condition is classed as moderately limiting their daily activities (referred to as functional class II or III — confirm with trial site)
  • Children who are already taking at least one approved medication for their lung blood pressure condition, and whose dose has been stable for at least 3 months before starting the trial

Who may not be able to join:

  • Children whose lung blood pressure condition is caused by liver-related high blood pressure, a parasitic infection called schistosomiasis, or certain rare lung vessel conditions (confirm with trial site)
  • Children whose condition is linked to Eisenmenger syndrome (a specific heart and lung complication — confirm with trial site)
  • Children who have previously taken a medication called selexipag (also known as Uptravi)
  • Children who have another serious, life-threatening illness where life expectancy is less than 12 months
  • Children who are pregnant, planning to become pregnant, or currently breastfeeding
  • Children who are known to be allergic to or unable to tolerate selexipag or any of its ingredients

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Actelion Clinical Trial, Actelion

Australian sites

Queensland CHILDREN'S HOSPITAL, South Brisbane,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Sponsor
Actelion
Registry
ClinicalTrials.gov
Start date
16 January 2020
Est. completion
11 October 2024

Where this trial is recruiting

🇦🇺 Australia Belarus 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇴 Colombia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇹 Lithuania 🇲🇾 Malaysia 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇷🇸 Serbia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇺🇦 Ukraine 🇺🇸 United States 🇻🇳 Vietnam

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Double-blind Period: Time to Disease Progression

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov