Phase 2 Pulmonary Hypertension Trial, Completed NCT02279745 Sponsor: United Therapeutics 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 enrolled 45 people with pulmonary arterial hypertension (a condition where blood pressure in the lungs is abnormally high) who were given an oral medicine called ralinepag. Of the 45 who started, 25 completed the trial and 20 did not finish. The trial was measuring several things related to how the heart and lungs were functioning, including the resistance blood faces when flowing through the lungs (called pulmonary vascular resistance), how much blood the heart pumps per minute (cardiac output and cardiac index), how far participants could walk in six minutes, and how long it took before their condition got measurably worse. The reported data shows that the average change in pulmonary vascular resistance from the start of the trial to the end was minus 52.2 units (dynes·sec/cm⁵), meaning the average measurement went down by that amount. The reported change in cardiac output was essentially zero (−0.0 litres per minute), and the reported change in cardiac index was also zero (0.0 litres per minute per square metre). For the six-minute walk test — where participants walk as far as they can in six minutes — the reported changes from baseline across multiple check-in points ranged from around 16 metres to 47 metres of additional distance. The reported data also shows that for the time until a first significant worsening event, the reported median (the middle value in the group) was 56.5 weeks. The reported data shows that for the functional class measure — a scale from I to IV describing how much a person's daily activity is limited by their condition — the numbers of participants in each category shifted somewhat across the different time points during the trial, though the detailed breakdown across all visits was not fully described in the submitted data. 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 2 Pulmonary Hypertension Trial, Completed

NCT02279745
Completed Phase 2 🇦🇺 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:

  • You signed and dated a consent form agreeing to take part in the study.
  • You were willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures for a long-term study.
  • If you are a woman, you were not pregnant or breastfeeding, and were either unable to have children naturally (due to surgery or menopause) or agreed to use an approved form of birth control for at least 3 months before the study, throughout, and for at least 30 days after the last dose.
  • If you are a man, you were either surgically unable to father children or agreed to use a condom with spermicide during the study and for 30 days after the last dose when having sex with a female partner not using birth control.
  • Both men and women agreed not to try to conceive a child during the study and for 30 days after the last dose.
  • You took part in and completed the earlier related study (Study APD811-003) as planned.
  • If you were in the placebo group in the earlier study and your condition got worse, you may still be able to join after completing all required end-of-study steps from that study.

Who may not be able to join:

  • You took part in the earlier study (APD811-003) but had to stop taking the study drug early because of a side effect or serious medical event, or you did not complete that study (with an exception for placebo participants whose condition worsened).
  • You are a woman who wishes to become pregnant.
  • Your systolic blood pressure (the top number in a blood pressure reading) was below 90 mmHg at the start of the study.
  • You had another serious medical condition or abnormal test result that could have put you at greater risk or affected the study results, as judged by the study doctor (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.

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 28 July 2026
Phase 2: approximately ~30% 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

Australian sites

St. Vincent's Hospital, Darlinghurst, New South Wales
The Prince Charles Hospital, Chermside, Queensland
Royal Hobart Hospital, Hobart, Tasmania
St Vincent's Hospital, Fitzroy, Victoria
Fiona Stanley Hospital, Murdoch,

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
United Therapeutics
Registry
ClinicalTrials.gov
Start date
8 July 2015
Est. completion
29 March 2021

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇿 Czechia 🇭🇺 Hungary 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Pulmonary Vascular Resistance; Change From Baseline in Cardiac Output; Change From Baseline in Cardiac Index; Change From Baseline in Mean Pulmonary Arterial Pressure

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: 28 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