A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension
This study is investigating a new medication called Baxdrostat for adults in the UK who have high blood pressure that isn't under control, even with their current medicines. Some participants in the study might have 'resistant hypertension,' meaning their blood pressure is particularly stubborn to treat. The main goal is to find out if Baxdrostat can effectively reduce blood pressure and if it's a safe treatment. Participants will receive either Baxdrostat or a placebo (a dummy pill with no active drug) to help researchers understand the drug's effects. This is a Phase 3 study, meaning it's a key step to see if Baxdrostat could become a widely available treatment.
At a glance
What is this study about?
This research study is looking at a new medicine called Baxdrostat for people who have high blood pressure that isn't well controlled, even after taking at least two different blood pressure medications. Some people in the study might have what's called 'resistant hypertension,' which means their high blood pressure is very difficult to treat, even with three or more strong blood pressure medicines.
The main aim of this study is to see if Baxdrostat can help lower blood pressure effectively. We'll also be checking carefully to make sure the medicine is safe and if people can take it without too many side effects. To do this, some people will receive Baxdrostat, while others will receive a 'placebo,' which looks just like the real medicine but doesn't contain any active drug. This helps us understand if any changes in blood pressure are truly due to Baxdrostat or other factors.
This is a 'Phase 3' study, which is an important stage in developing new medicines. It means researchers are trying to confirm if Baxdrostat is effective and safe on a larger group of people. The results of studies like this help decide if a new medicine should be approved for wider use to help people with uncontrolled high blood pressure.
Key takeaways
- This study is for adults with high blood pressure that's hard to control.
- It's testing a new medicine called Baxdrostat to see if it lowers blood pressure.
- You might receive the new medicine or a dummy pill (placebo).
- Participation involves regular clinic visits and health checks.
- The study aims to find out if Baxdrostat is safe and works well.
- You can stop participating at any time.
Who may be eligible?
The study is looking for adults aged 18 and over, of any gender. You might be suitable if you have high blood pressure (hypertension) that is currently not well-controlled, even though you are already taking at least two different medications for it. One of these medications must be a 'diuretic,' which helps your body get rid of extra salt and water.
Also, if your high blood pressure is particularly stubborn and not coming down despite taking at least three different blood pressure medications at their highest-tolerated doses, including a diuretic, you might also be considered for this study.
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 high blood pressure that's not well controlled?
- Are you currently taking at least two blood pressure medications (one being a water tablet)?
- Are you willing to attend regular clinic appointments?
What does participation involve?
If you join this study, you'll be assigned by chance to either receive Baxdrostat or a placebo (a dummy pill). Neither you nor your study doctor will know which one you're taking. You'll have regular visits to the clinic where your blood pressure will be checked carefully. You'll also have blood tests and other examinations to monitor your health and how the medicine is affecting you. The exact number of visits and the total length of your participation will be discussed with you, but typically, these types of studies involve several clinic visits over many weeks or months. You will receive the study medication for a certain period, and there will be follow-up appointments even after you stop taking the drug.
Potential risks and benefits
Locations (14)
- —UnverifiedNetherlands
- —UnverifiedBulgaria
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedSlovakia
- —UnverifiedItaly
Common questions
What is 'uncontrolled hypertension'?
It means your blood pressure is still too high, even though you're taking two or more blood pressure medicines, including a water tablet (diuretic).
What is 'resistant hypertension'?
This is when your blood pressure is very difficult to lower, even with at least three strong blood pressure medicines, including a water tablet (diuretic).
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers see if the real medicine is truly making a difference.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the real medicine (Baxdrostat) or the placebo. This helps prevent bias in the results.
How long will I be in the study?
The full length of your participation will be explained by the study team, but typically these studies involve regular check-ups over several months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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