A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is high blood pressure in the blood vessels supplying the lungs. It can cause breathlessness, tiredness, and limit everyday activities. This phase 2 clinical trial is testing a new tablet called NS-863 to see if it helps adults with PAH. Researchers want to find the best dose and check how safe the medicine is. They will see if it lowers resistance in the lung arteries, makes walking easier, and improves daily quality of life. Participants will be chosen by chance to take either the study medicine or a dummy pill (placebo) for around 24 weeks. Neither you nor your doctor will know which one you are taking until the end. Taking part involves health checks such as walking tests, heart scans, and blood tests to carefully track your wellbeing.
At a glance
What is this study about?
Pulmonary arterial hypertension (PAH) is a serious, long-term condition where the blood vessels carrying blood from the heart to the lungs become stiff and narrowed. This makes it harder for the heart to pump blood through them, raising blood pressure in the lungs. Over time, this extra strain can make people feel very breathless, exhausted, and dizzy during ordinary daily tasks.
This clinical trial is looking at a new medicine called NS-863, taken by mouth as a tablet. The main goal is to find out if NS-863 can relax and widen these blood vessels, lowering the resistance the heart has to pump against. Scientists also want to test different doses to discover which amount works best while causing the fewest side effects.
Because current treatments may not work well for everyone, finding new options is vital. By testing whether NS-863 improves blood flow, eases breathing, and helps people walk further, this research could lead to better treatments for people living with PAH in the future.
Key takeaways
- Tests a new oral tablet (NS-863) for pulmonary arterial hypertension.
- Open to adults aged 18 and older diagnosed with PAH.
- Compares different doses of the medicine against a dummy tablet (placebo).
- Treatment and monitoring last for approximately 24 weeks.
- Involves walking tests, heart scans, and regular health checks.
- Participation is voluntary and you can leave at any point.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with pulmonary arterial hypertension (PAH). Both men and women can take part.
To join, participants need to be well enough to complete regular hospital checks, such as walking tests and heart scans. You will also need to be able to swallow tablets.
Certain people may not be able to take part. For example, people with other serious heart or lung conditions, severe kidney or liver problems, or those who are pregnant or breastfeeding may not be eligible for safety reasons. The study team will review your full medical history before you join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with pulmonary arterial hypertension (PAH).
- I am able and willing to swallow tablets daily.
- I can attend regular hospital appointments over a 24-week period.
- I am able to carry out short walking tests and routine health checks.
What does participation involve?
If you take part, you will be placed into a group by chance (randomly). You will receive either the study medicine (NS-863) at a specific dose or a dummy tablet (placebo) that looks identical but has no active ingredients. You will take your assigned tablets by mouth every day for about 24 weeks.
During the trial, you will have regular clinic visits. At these visits, doctors will measure the pressure in your blood vessels, carry out heart scans (echocardiograms), and record your heart rhythm with ECGs. You will also do a 6-minute walking test to see how far you can walk comfortably, answer questionnaires about your breathing and energy levels, and provide routine blood and urine samples.
The entire study lasts around six months. The medical team will stay in close contact with you throughout to check on your health and support you at every step.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedGreece
Common questions
What is a placebo and why is it used?
A placebo is a dummy pill that looks just like the real medicine but contains no active drug. It helps researchers prove whether any improvements or side effects are truly caused by NS-863.
Can I choose whether I get the study drug or the placebo?
No. A computer assigns you to a group by chance. Neither you nor your study doctor can choose your group, and neither will know which you are taking during the trial.
Will taking part cost me anything?
No. The study medication, clinic visits, and tests are provided free of charge. Most trials also offer help with travel expenses to and from the hospital.
Can I keep taking my usual PAH medications?
In many cases, yes. The study team will carefully check all the medicines you currently take to make sure they can be safely combined with the trial treatment.
What happens if I change my mind during the trial?
Taking part is completely voluntary. You can choose to stop at any time, for any reason, and your regular medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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