RecruitingPHASE3INTERVENTIONAL

A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

This study is looking at a new medicine called Baxdrostat for people who have high blood pressure due to a common condition called primary aldosteronism. In this condition, the body produces too much of a hormone called aldosterone, which can raise blood pressure. Researchers want to find out if Baxdrostat is safe and effective at lowering blood pressure and helping to get the body's hormone levels back to normal. Participants will either receive Baxdrostat or a placebo (a dummy pill) once a day. The study will last for a period of time, with regular check-ups to see how participants are doing and if the medicine is working. This is a large study taking place in many hospitals across different countries.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

250

Start

07 Aug 2025

Estimated completion

18 Feb 2028

Primary Hyperaldosteronism

What is this study about?

This study is about a new medicine called Baxdrostat that could help people with a condition known as primary aldosteronism. If you have primary aldosteronism, your body makes too much of a hormone called aldosterone. This extra aldosterone can lead to high blood pressure, which, if left untreated, can put you at risk for heart problems and other health issues.

The main goal of this study is to see if Baxdrostat is safe to use and if it can effectively lower blood pressure in people with primary aldosteronism. Researchers will also check to see if it helps to bring the levels of certain hormones in your body back into balance. They will compare Baxdrostat to a 'placebo', which looks like the real medicine but contains no active drug. This helps them understand the true effects of Baxdrostat.

Taking part in a study like this helps doctors learn more about new treatments. Your involvement could help others with primary aldosteronism in the future. The study is carefully planned and supervised by medical experts to ensure participant safety and reliable results.

Key takeaways

Tests a new medicine, Baxdrostat, for high blood pressure from primary aldosteronism.
Compares Baxdrostat to a dummy pill (placebo) to see if it's safe and effective.
Participation involves taking daily medicine and attending regular check-ups.
You will be closely monitored by medical professionals throughout the study.
Helps advance medical understanding for people with primary aldosteronism.
You can choose to leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of primary aldosteronism. You should also have high blood pressure that falls within a specific range, even if you're taking other blood pressure medicines. Your kidneys need to be working well, and your blood potassium levels should be stable.

There are also some reasons why you might not be able to join. For example, if you've already had surgery for your condition or are planning to have certain procedures, you wouldn't be eligible. Also, if you have other specific serious heart conditions, very low sodium levels, or other known causes of high blood pressure that aren't primary aldosteronism, you unfortunately couldn't take part.

If you're currently taking certain water pills (diuretics) or other specific medications for your condition, you would need to be willing to stop them for a short time before starting the study. The study team will explain all the specific requirements in detail to see if you're a good fit.

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 primary aldosteronism?
Is your kidney function generally good?
Are you able to stop certain blood pressure medications if needed for the study?
Do you have high blood pressure within a specific range?
Have you not had certain surgeries for your condition or other specific health issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive Baxdrostat or a placebo (a dummy pill, which looks the same but has no active medicine). You'll take your study medicine once a day. The dose might be adjusted after two weeks depending on how you're responding and if you're experiencing any side effects.

You'll have regular hospital visits for check-ups, blood tests, and to measure your blood pressure. These appointments help the study team monitor your progress and ensure your safety. The study involves multiple visits over a period of time, and the exact total duration will be explained to you. You'll need to follow the study instructions carefully, including taking your medicine as prescribed and attending all scheduled appointments. This is a global study, so if you're eligible, you'll be joining participants from many centers in different countries.

Potential risks and benefits

By taking part, you might benefit from receiving a new medicine that could help manage your blood pressure if the standard treatments haven't worked well for you. Even if you receive the placebo, strict monitoring of your blood pressure and health will be provided. Like all medicines, Baxdrostat might have side effects, and some blood tests or procedures carry small risks, which the study team will explain fully. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (89)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Los Angeles, United States· Not yet recruiting
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San Francisco, United States· Not yet recruiting
Research Site
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Farmington, United States· Not yet recruiting
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Chicago, United States· Not yet recruiting
Research Site
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Springfield, United States· Recruiting
Research Site
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Baltimore, United States· Not yet recruiting
Research Site
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Boston, United States· Recruiting
Research Site
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Boston, United States· Recruiting
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Ann Arbor, United States· Recruiting
Research Site
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Rochester, United States· Recruiting
Research Site
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Olive Branch, United States· Recruiting
Research Site
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Kansas City, United States· Withdrawn

Common questions

What is primary aldosteronism?

It's a condition where your body makes too much of a hormone called aldosterone, which can cause high blood pressure.

What is a placebo?

A placebo is a dummy pill that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.

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 doctor will know if you're receiving Baxdrostat or the placebo until after the study ends.

How long will the study last?

The exact duration will be explained by the study team, but it involves regular visits over a period to monitor your progress.

Can I stop participating in the study if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without affecting your medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.