A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients (ADVANCE Outcomes)
This research study, called ADVANCE Outcomes, is investigating a new medication, Ralinepag, for adults with pulmonary arterial hypertension (PAH). PAH is a serious lung condition where blood vessels in the lungs become narrow, making it hard for the heart to pump blood. The main aim is to find out if Ralinepag can delay or stop the condition from getting worse. Researchers will compare Ralinepag to a dummy pill (placebo) to understand how well it works and if it's safe. It's a large, important study in its final stages before a medicine might be considered for wider use.
At a glance
What is this study about?
This study is called ADVANCE Outcomes and it's looking into a new medication called Ralinepag for people who have a condition called Pulmonary Arterial Hypertension, or PAH. PAH is a serious lung disease where the blood vessels in your lungs become narrow and stiff. This makes it really hard for your heart to pump blood through your lungs, leading to symptoms like shortness of breath and tiredness.
Doctors want to know if Ralinepag can help people with PAH live better and prevent their condition from getting worse over time. They are particularly interested in seeing if patients taking Ralinepag go longer without experiencing a significant worsening of their symptoms or needing more intensive treatment. This is a crucial step in developing new treatments for PAH, as finding medicines that can slow down or stop the progression of the disease is very important.
To make sure the results are reliable, some patients in the study will receive Ralinepag, while others will receive a 'dummy pill' called a placebo. This comparison helps doctors understand if any improvements are genuinely due to the medicine or just a natural change. This type of study is called a 'Phase III' trial, which means it's one of the final stages of testing a new medicine before it can be approved for common use.
Key takeaways
- This study evaluates a new treatment, Ralinepag, for Pulmonary Arterial Hypertension (PAH).
- It aims to see if Ralinepag can slow down or prevent the worsening of PAH.
- Participants will receive either Ralinepag or a placebo (dummy pill).
- It's a Phase III study, close to the final stage of drug testing.
- Regular hospital visits and careful monitoring are part of taking part.
Who may be eligible?
To be able to take part in this study, you need to be an adult, which means you must be 18 years old or older. There is no upper age limit, so older adults can also be considered.
Both men and women are welcome to participate in this research. The study needs a wide range of people to make sure the results apply to everyone with the condition.
Beyond age and sex, there will be other specific health requirements that your doctor will check. These are important to make sure the study is safe for you and that the results are clear, so be ready to discuss your full medical history with the study team.
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 willing to take a study medication, which could be Ralinepag or a placebo?
- Are you able to attend regular check-up appointments at the hospital or clinic?
What does participation involve?
If you decide to join this study, you will be given either the study medicine, Ralinepag, or a dummy pill (placebo) to take. You won't know which one you're getting, and neither will your local doctor, so the results are fair.
Throughout the study, you will have regular visits to your clinic or hospital. During these visits, the study team will carry out various check-ups, like taking blood samples, monitoring your heart (ECGs), asking about your symptoms, and possibly performing walking tests to see how your body is responding. These checks help them understand how the medicine is working and to keep you safe.
While the exact total duration wasn't specified, studies like this often last for a year or more, depending on how long it takes to see the effects of the treatment. You will be closely monitored until the end of the study or if you stop taking the study medication.
Potential risks and benefits
Locations (15)
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedDenmark
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedGreece
Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a serious lung condition where the blood vessels in your lungs become narrow, making it hard for your heart to pump blood.
What is Ralinepag?
Ralinepag is the name of the new medicine being tested in this study for PAH.
What does 'Phase III' mean?
Phase III means this is one of the final stages of testing a new medicine before it might be approved for wider use.
Will I know if I'm getting the real medicine or a dummy pill?
No, you won't know if you're getting Ralinepag or a placebo. This is to ensure the study results are unbiased.
How long will the study last?
The information doesn't specify the exact total duration, but studies like this often last for a year or more.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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