IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)
The IMPAHCT study is testing a new medicine called AV-101 for people with Pulmonary Arterial Hypertension (PAH). PAH is a serious condition where blood pressure in the arteries leading to the lungs is too high, making the heart work harder. This study is in two main parts, Phase 2b and Phase 3, run together. Researchers want to find out if AV-101 is safe and if it helps people walk further or lowers the pressure in their lungs, compared to a placebo (a dummy treatment). They will also look at how it affects other important health markers and overall quality of life. This research aims to see if AV-101 could be a helpful new option for people living with PAH.
At a glance
What is this study about?
This clinical trial, called IMPAHCT, is looking into a new medicine called AV-101 for a condition called Pulmonary Arterial Hypertension, or PAH. PAH is a serious and long-lasting condition where the blood vessels in the lungs become narrow, stiff, or blocked. This makes it harder for the heart to pump blood through the lungs, which can lead to symptoms like shortness of breath, tiredness, and chest pain. The study hopes to find out if AV-101 can help open up these blood vessels and improve how well people with PAH feel and function.
The study is designed in a way that allows researchers to compare the new medicine directly with a placebo, which is a dummy treatment that looks just like the real medicine but contains no active drug. This is important because it helps scientists understand if any changes seen in participants are truly due to the medicine or just because they are expecting to feel better. Participants will not know if they are receiving the real medicine or the placebo, and neither will their study doctors – this is called a 'double-blind' study and helps ensure the results are as fair and accurate as possible.
Throughout the study, which will last for 24 weeks, researchers will measure several things. For some parts of the study, they'll focus on how the medicine affects the pressure in the lung arteries. For other parts, they'll measure how far participants can walk in six minutes – this is a common way to check someone's overall fitness and how well their heart and lungs are working. They will also look at other important health markers, how the condition affects daily life, and any side effects people might experience.
Key takeaways
- This study is testing a new medicine (AV-101) for Pulmonary Arterial Hypertension (PAH).
- It's a 'double-blind' study, meaning some participants get the new medicine and others get a dummy pill (placebo).
- Researchers will study safety and how well the medicine works by measuring lung pressure and walking ability.
- The study lasts for 24 weeks with regular clinic visits.
- Both men and women, aged 18 and older, can be considered for the study.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part.
Both men and women are welcome to participate in this study. The researchers want to include a wide range of people to make sure the results apply to as many individuals as possible who have Pulmonary Arterial Hypertension (PAH).
Beyond age and sex, there will be other specific health requirements that your doctor will discuss with you. These are in place to ensure your safety and that the study design is suitable for your particular health situation.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of Pulmonary Arterial Hypertension (PAH)?
- Are you able to attend regular clinic visits for 24 weeks?
- Are you willing to potentially receive a placebo (dummy treatment)?
What does participation involve?
If you decide to take part in this study, you'll be assigned to either receive the new medicine (AV-101) or a dummy medicine (placebo) for 24 weeks. This decision is made by chance, like flipping a coin, and neither you nor your study doctor will know which you are receiving. During these 24 weeks, you'll have regular visits to the clinic so the research team can monitor your health, perform various tests, and check how you're responding to the treatment.
These assessments will include physical exams, blood tests, and possibly tests like the six-minute walk test. This test measures how far you can walk in six minutes and is a way for doctors to see how your heart and lungs are working. You will also be asked to answer questions about your quality of life and how you are feeling generally. The total duration of active treatment and follow-up in the trial is planned for 24 weeks.
Potential risks and benefits
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Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a condition where the blood pressure in the arteries leading to your lungs is too high, making your heart work harder.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real treatment but contains no active drug. It helps researchers understand if the new medicine really works.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is over.
How long will the study last?
Participants will receive the study medicine or placebo for 24 weeks, with regular check-ups during this time.
What is a 'six-minute walk test'?
It's a common test where you walk as far as you can in six minutes. It helps doctors see how well your heart and lungs are working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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