A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension.
This research trial is investigating a new medication called Baxdrostat. It's designed for adults who have 'resistant hypertension,' which means their blood pressure stays high despite taking at least three different blood pressure medications, including a water tablet, at their highest safe doses. Participants will either receive Baxdrostat or a placebo (a dummy pill, with no active medicine) for 12 weeks. Neither the participants nor their doctors will know who is getting which. The main goal is to find out if Baxdrostat can reduce average blood pressure measured over 24 hours more effectively than the dummy pill. We'll also look at how it affects daytime and nighttime blood pressure, as well as seated blood pressure.
At a glance
What is this study about?
Imagine your blood pressure is like the pressure in a water pipe. If it's too high, it can damage your pipes over time. High blood pressure, or hypertension, is a very common condition, and for most people, it can be managed with medication. However, some people have what doctors call 'resistant hypertension.' This means that even after taking a combination of three or more different blood pressure medicines, including a 'water tablet' (which helps your body get rid of extra salt and water), their blood pressure still remains too high.
This study is looking at a new medication called Baxdrostat. We want to see if Baxdrostat can help people with resistant hypertension finally get their blood pressure under control. By lowering persistently high blood pressure, we aim to reduce the risk of serious health problems like heart attacks and strokes. This is important because finding new ways to treat resistant hypertension could significantly improve the health and well-being of many people. The study is particularly interested in how Baxdrostat affects your blood pressure throughout the day and night, not just when you're at the doctor's office.
This is a 'Phase III' study, which means Baxdrostat has already been tested in smaller groups of people and shown some promising results. Now, we need to confirm these findings in a larger group to see if it's safe and effective enough for wider use. By taking part, you could help researchers understand if Baxdrostat could become a new treatment option for resistant hypertension.
Key takeaways
- This study tests a new drug, Baxdrostat, for very difficult-to-treat high blood pressure.
- It's for adults whose blood pressure is still high despite taking multiple medications.
- Participants will receive either Baxdrostat or a dummy pill (placebo).
- Blood pressure will be carefully measured over 24 hours.
- Your involvement could help identify a new treatment option for resistant high blood pressure.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. We are looking for both men and women.
The most important requirement is that you have resistant high blood pressure. This means your doctor has diagnosed you with high blood pressure that remains too high, even though you are already taking at least three different types of blood pressure medications at their maximum safe doses. One of these medications must be a 'water tablet', also known as a diuretic.
There will be other health checks and medical history reviews to ensure your safety and suitability for the study. For example, certain other medical conditions or medications might mean you can't take part. These will be discussed with you in detail by the study doctor.
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?
- Has your doctor told you that you have high blood pressure that is hard to control?
- Are you currently taking at least three different blood pressure medications, including a water tablet?
- Is your blood pressure still higher than recommended levels despite these medications?
What does participation involve?
If you decide to take part, you'll be in the study for about 12 weeks. During this time, you'll have regular visits to the clinic where study doctors and nurses will monitor your health. You'll be given either the new medicine, Baxdrostat, or a placebo (a dummy pill with no active drug). You won't know which one you're taking, and neither will your study doctor. This is to ensure the results are as fair as possible.
Your blood pressure will be measured carefully and regularly, including using a portable device that measures your blood pressure at different times over 24 hours while you go about your daily activities. You'll also have blood tests and other examinations to check your general health and how you're responding to the treatment. All study-related appointments and medications will be provided free of charge.
Potential risks and benefits
Locations (9)
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedSlovakia
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedCzechia
Common questions
What is 'resistant hypertension'?
It means your blood pressure stays high even after taking three or more different blood pressure medicines, including a 'water tablet', at their highest safe doses.
What is Baxdrostat?
Baxdrostat is a new medication being tested to see if it can help lower blood pressure in people with resistant hypertension.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the study medication but contains no active drug. It helps us compare the effects of the new medicine.
Will I know if I'm getting the drug or the placebo?
No, this is a 'blinded' study, so neither you nor your study doctor will know which treatment you are receiving until after the study ends.
How long will the study last?
Your active participation in the study will last for about 12 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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