Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Assessing Baxdrostat to Identify Primary Aldosteronism in Adults Newly Diagnosed with Untreated Hypertension

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have recently been diagnosed with untreated Hypertension and are being evaluated for Primary aldosteronism, a condition in which the body produces too much of a hormone called aldosterone, leading to higher blood pressure. Participants will receive the oral medication Baxdrostat in tablet form at a dose of 2 mg once daily.

The main goal is to estimate how the top number of the blood pressure reading, known as SBP, changes after starting the drug and to see whether this change can help distinguish people who have the hormone excess condition (PASP) from those who do not (PASN). Blood pressure will be measured at home and in the clinic at the start of the study and again around days 15, 28, and 56. Blood tests will also be done to check levels of aldosterone, the hormone that raises blood pressure, and renin, a hormone that helps control blood pressure; the relationship between these two numbers is called the ARR. Other laboratory values such as PRA and DRC may be measured to further characterize hormone activity.

Throughout the roughly eight‑week period, participants will have regular visits where vital signs, weight, and any side effects will be recorded. Safety checks will include monitoring for high potassium (hyperkalaemia) or low sodium (hyponatremia) in the blood, as well as routine laboratory tests. The study is open label, meaning everyone knows the medication being taken, and no placebo is used.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit and Assessments

    You will attend a baseline visit where your seated blood pressure will be measured both at the clinic and at home.

    Blood samples will be taken to determine plasma aldosterone concentration, plasma renin activity (PRA), and the aldosterone‑to‑renin ratio (ARR) in order to confirm primary aldosteronism and hypertension.

    A physical examination, body weight measurement, and basic laboratory tests will be performed to establish your health status before starting the study medication.

  2. Step 2

    Start of Study Medication

    You will begin taking Baxdrostat tablets at a dose of 2 mg taken orally once each day.

    The medication will be taken for a total period of 56 days (8 weeks) unless you experience a serious adverse event that requires discontinuation.

  3. Step 3

    Daily Home Blood Pressure Monitoring

    Each day you will measure your seated blood pressure at home using a validated device.

    Record the systolic blood pressure (SBP) and diastolic blood pressure (DBP) values in the study diary provided to you.

    These daily readings will be used to evaluate how your blood pressure changes after starting Baxdrostat.

  4. Step 4

    First Follow‑Up Visit (Day 15)

    At approximately day 15 of treatment you will return to the clinic for a follow‑up visit.

    Your seated SBP and DBP will be measured in the office, and additional blood samples will be collected to assess changes in aldosterone, renin, and ARR.

    Safety laboratories will be checked for possible hyperkalaemia (high potassium) and hyponatremia (low sodium).

  5. Step 5

    Second Follow‑Up Visit (Day 28)

    Around day 28 you will have another clinic visit.

    Office blood pressure measurements will be repeated, and further blood tests will be performed to monitor hormone levels and safety parameters.

    Any adverse events (AEs) you have experienced will be reviewed and recorded.

  6. Step 6

    Final Visit and End of Study (Day 56)

    On day 56 you will attend the final study visit.

    Your seated SBP and DBP will be measured, and blood samples will be taken to evaluate the overall change from baseline.

    A complete safety assessment, including laboratory tests and review of any adverse events, will be performed.

    You will discontinue Baxdrostat after this visit unless your physician advises otherwise.

  7. Step 7

    Safety Monitoring Throughout the Trial

    Throughout the 56‑day period you should report any symptoms such as dizziness, muscle weakness, or unusual changes in blood pressure to the study team promptly.

    Serious adverse events (SAEs) and any events leading to discontinuation of the medication will be documented and evaluated.

Who can join the trial?

7 criteria

  • You must be between 18 and 75 years old when you sign the consent form.
  • You must have a new diagnosis of high blood pressure (hypertension) that has not been treated before. This means the average reading taken at the doctor’s office is 140/90 mmHg or higher, or the average reading you take at home is 135/85 mmHg or higher. (mmHg stands for millimeters of mercury, the unit used for blood pressure.)
  • Your high blood pressure must stay high during a short check‑in period. Over at least five days you will measure your blood pressure at home twice each day, and the average systolic (top number) should be 135 mmHg or higher, or the diastolic (bottom number) 85 mmHg or higher. In addition, the average reading taken at the clinic on the screening day must be 140 mmHg systolic or higher, or 90 mmHg diastolic or higher.
  • Your kidney function must be adequate, measured by a test called estimated glomerular filtration rate (eGFR). The result must be 60 mL/min/1.73 m² or higher.
  • The amount of potassium in your blood must be between 3.5 and 5.0 mmol/L (millimoles per liter).
  • You must be a person who was assigned female at birth (including all gender identities) and you must use birth‑control methods that follow the study’s local rules.
  • You must be able to read, understand, and sign the informed consent form.

Who cannot join the trial?

23 criteria

  • If the doctor thinks there is any reason you should not join the study.
  • If you have a serious heart‑rhythm problem called cardiac conduction abnormality, found in your medical history or on an ECG.
  • If you have had ketoacidosis, a dangerous condition where the body makes too many acids because of low insulin.
  • If your sitting blood pressure is very high – systolic (top number) ≥ 170 mmHg or diastolic (bottom number) ≥ 105 mmHg – measured after you have been seated for at least five minutes.
  • If you are taking, or plan to take, medicines that could interfere with the study results or increase safety risks.
  • If you are allergic (hypersensitive) to Baxdrostat, drugs in the same class, or any of its ingredients.
  • If you have participated in another clinical trial with an experimental drug in the past three months (or longer, depending on the drug’s half‑life).
  • If you have used blood‑pressure medicines (antihypertensive drugs) within four weeks before screening.
  • If your blood sodium level (serum sodium) is low – less than 135 mmol/L – at screening.
  • If you have any known secondary cause of high blood pressure, such as acute kidney injury (AKI) or chronic kidney disease (CKD), narrowing of the kidney artery (renal artery stenosis), uncontrolled overactive thyroid (hyperthyroidism) or underactive thyroid (hypothyroidism), hormone‑producing tumors (pheochromocytoma), Cushing’s syndrome, narrowing of the aorta (aortic coarctation), or known/suspected excess aldosterone (hyperaldosteronism) or an adrenal gland mass.
  • If you have the most severe class of heart‑failure symptoms (New York Heart Association class IV) at screening.
  • If you have ongoing irregular heart rhythm called atrial fibrillation.
  • If you have a history of stroke, heart attack (acute coronary syndrome), severe high‑blood‑pressure brain injury (hypertensive encephalopathy), or hospitalization for heart failure within the past six months.
  • If you are planning, or have had within six months, a heart procedure such as angioplasty (percutaneous coronary intervention) or coronary artery bypass surgery (coronary artery bypass grafting).
  • If you have a severe blockage of blood leaving the left side of the heart, such as obstructive hypertrophic cardiomyopathy or severe aortic valve disease.
  • If you work rotating or irregular hours that disturb your sleep‑wake pattern, making blood‑pressure measurements unreliable.
  • If you have serious liver disease (severe hepatic impairment), defined as Child‑Pugh Class C or liver enzymes (AST/ALT) more than three times the normal limit with high bilirubin, unless you have Gilbert’s syndrome.
  • If you have uncontrolled diabetes, meaning your average blood‑sugar level (HbA1c) is higher than 10 % (86 mmol/mol) at screening.
  • If your resting heart rate is very low (below 45 beats per minute) or very high (above 110 beats per minute).
  • If doctors think you may have severe thickening of the heart muscle (cardiac hypertrophy).
  • If you are pregnant, breastfeeding, planning to become pregnant during the study, or plan to become pregnant within 30 days after the last dose; donating eggs is also not allowed.
  • If you have adrenal insufficiency, meaning your adrenal glands do not make enough hormones.
  • If you have had a high potassium level (> 5.5 mmol/L) in the past year, unless it was a lab error and a repeat test was normal; confirmed high potassium not due to lab error excludes you.
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Baxdrostat is an oral tablet that is being tested in this study. It is given once a day to see how it changes a person’s blood pressure when they have untreated high blood pressure. By watching the blood‑pressure response, researchers hope to learn whether the drug can help doctors tell the difference between two forms of primary aldosteronism – one where the body makes too much aldosterone and another where it does not. This information could make it easier to choose the right treatment for each patient.

What is already known about the treatment

Baxdrostat - Baxdrostat is taken by mouth as a tablet, typically 2 mg once daily. It is an investigational medicine that is still being studied in clinical trials and has not yet received market approval. The drug is being tested for use in people with primary aldosteronism and high blood pressure. It works by blocking the enzyme that makes aldosterone, which helps lower the amount of this hormone and reduces blood pressure. Baxdrostat belongs to the class of aldosterone synthase inhibitors.

Investigated diseases

  • Primary aldosteronism

    A disorder in which the adrenal glands produce excess aldosterone, a hormone that makes the kidneys retain sodium and lose potassium. The resulting fluid retention raises the amount of blood in the vessels, leading to higher blood pressure. Over time, the condition can cause the blood pressure to increase steadily if the hormone excess continues.

  • Hypertension

    A long‑term condition characterized by consistently elevated blood pressure in the arteries. The pressure rise often develops slowly and may be influenced by lifestyle, genetics, and other health factors. As the pressure remains high, the heart and blood vessels work harder, which can lead to gradual changes in their structure and function.

Trial detailsLast updated 14 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527692-28-00Protocol codeD6974C00002,CRC.0053Estimated enrolment289 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.