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 (NCT02279160) looked at a drug called APD811 in people with pulmonary arterial hypertension (PAH) — a condition affecting blood pressure in the lungs. A total of 61 people took part: 40 received APD811 and 21 received a placebo (a dummy treatment with no active ingredient). Of those, 34 in the APD811 group and 19 in the placebo group completed the study. The trial measured two main things: the resistance to blood flow through the lungs (called pulmonary vascular resistance, or PVR — essentially how hard the heart has to work to push blood through the lung vessels), and how far participants could walk in six minutes (a standard test of physical capacity in this condition). The reported data shows that, when looking at the change in lung blood-flow resistance from the start of the study to around Week 22, the APD811 group had a baseline PVR value of 514.6 units (dyn·sec/cm⁵) and the placebo group had a baseline value of 512.0 units. For the six-minute walk test, the reported baseline distance was 36.2 metres in the APD811 group and 29.4 metres in the placebo group. It is important to note that the data as submitted reports these as baseline figures; the actual change-from-baseline results for each outcome were not separately reported in the structured data available, so those figures cannot be described here. 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 31391223) ↗
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
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 between 18 and 75 years old (inclusive)
- You have been diagnosed with a specific type of pulmonary arterial hypertension (high blood pressure in the lungs) known as WHO Group 1 PAH, which includes idiopathic (unknown cause), heritable (genetic), drug- or toxin-related, or PAH linked to connective tissue disease, HIV, or congenital heart disease
- Your PAH diagnosis has been confirmed by a heart catheterization procedure
- Your PAH symptoms fall into a moderate-to-severe range based on a standard classification system (WHO/NYHA functional class II–IV)
- You were previously diagnosed with PAH and are currently on a stable oral PAH medication — either an ERA and/or a medication that works through the nitric oxide pathway (such as a PDE5 inhibitor or a soluble guanylate cyclase stimulator) — with no dose changes in the last 3 months
- You are able to walk between 100 and 500 metres in a 6-minute walk test, with two test results within 15% of each other on separate days during screening
- You have had lung function tests within the past 6 months showing no signs of significant lung tissue disease
- You have had a specific lung scan (V/Q scan) or pulmonary angiogram within the past 5 years, taken at or after your PAH diagnosis, showing no blood clots in the lungs
- If you are taking certain medications such as vasodilators, digoxin, spironolactone, or L-Arginine, your dose has been stable for at least 1 month before screening
Who may not be able to join:
- You have just been diagnosed with PAH and are not yet on any PAH-specific treatment
- You have taken part in a clinical trial involving an experimental drug, biological treatment, or device within the past 2 months
- You have had a sudden worsening of heart failure within the past month
- Your systolic (upper number) blood pressure is below 90 mmHg at screening
- You have a history or current evidence of left-sided heart disease or other significant heart conditions
- You have used a prostacyclin or prostacyclin-type medication for more than 30 days within the past 3 months
- You previously used a prostacyclin or prostacyclin-type medication but had to stop it due to safety or tolerability concerns related to how the drug works
- You have another serious medical condition or abnormal test result that the trial doctor believes could put you at risk or affect the trial results (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
Principal Investigator: Derek Solum, PhD, United Therapeutics
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
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 (PVR); Change From Baseline in 6-minute Walk Distance (6MWD) in Patients With PAH
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.