Study of baxdrostat compared to placebo to treat adults with primary aldosteronism

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What is this study about?

This study focuses on Primary Aldosteronism, a condition where the body produces too much of a hormone called aldosterone. The study will test a medication called Baxdrostat (also known as CIN-107) to see how well it works and how safe it is for treating this condition. Primary Aldosteronism can cause high blood pressure and changes in blood potassium levels.

The study will compare Baxdrostat tablets with placebo in adults who have Primary Aldosteronism. During the study, participants will take either Baxdrostat or placebo orally each day. The medication dose may range from 2 to 4 milligrams per day. The main purpose is to determine if Baxdrostat can help lower blood pressure in people with this condition.

The treatment period will last for about one year (52 weeks). Throughout the study, participants will have their blood pressure monitored, and doctors will check various health measurements including hormone levels in blood and urine. The study will also track how the medication affects potassium levels in the blood.

1 Initial evaluation

Your eligibility for the study will be confirmed based on the following criteria:

– Age must be 18 years or older

– Confirmed diagnosis of primary aldosteronism (a condition with excess hormone production)

– Kidney function test result (eGFR) must be 45 mL/min/1.73m2 or higher

– Blood potassium level must be between 3.0 and 5.0 mmol/L

– Blood pressure reading must show systolic pressure of 135 mmHg or higher

2 Medication adjustment period

If you are currently taking certain blood pressure medications (mineralocorticoid receptor antagonists or potassium-sparing diuretics), you will need to stop taking them

Your other blood pressure medications must remain unchanged for at least 4 weeks before the study begins

3 Treatment period – First 8 weeks

You will receive either baxdrostat tablets or placebo tablets (tablets with no active medication)

The tablets should be taken by mouth according to the provided schedule

Your blood pressure will be monitored regularly

Blood tests will be performed to check your potassium levels and other parameters

4 Extended treatment period

The study continues through week 52

Regular monitoring of your blood pressure will continue

Additional tests will measure hormone levels in your blood and urine

Your kidney function will be monitored through urine tests

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have a confirmed diagnosis of Primary Aldosteronism (a condition where the body produces too much of a hormone called aldosterone) according to specific medical guidelines
  • Must be willing to stop taking certain medications called mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics (medications that help remove excess water from the body while keeping potassium)
  • Must have a kidney function test (eGFR) result of 45 or higher at screening (this test measures how well your kidneys are working)
  • Must have a blood potassium level between 3.0 and 5.0 mmol/L at screening
  • Must be on a stable dose of blood pressure medications for at least 4 weeks before starting the study
  • Must have an average seated systolic blood pressure (the top number in a blood pressure reading) of 135 or higher when measured by an automatic blood pressure monitor

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • History of heart attacks or myocardial infarction (damage to heart muscle due to blocked blood flow)
  • Uncontrolled diabetes mellitus (high blood sugar levels)
  • Severe kidney disease or renal impairment
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • History of substance abuse within the past 12 months
  • Severe liver disease or hepatic dysfunction
  • Known allergies to the study medication or its components
  • Major surgery within the last 3 months
  • Malignancy (cancer) within the past 5 years, except for successfully treated skin cancer
  • Inability to provide informed consent
  • Psychiatric conditions that could interfere with study participation
  • History of non-compliance with medical treatments
  • Life expectancy less than 12 months due to any medical condition

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Praxis Reinfeld Mitte Reinfeld Germany
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Kardiopraxis Schirmer Kaiserslautern Germany
Virgen del Rocío University Hospital Sevilla Spain
Universita Degli Studi Di Brescia Brescia Italy
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Aakntsaokp Peplarhe Hmnjzjat Dp Mapnylxxv Marseille France
Axwulbz Ojhquzekmqn Uujbrvyfzrnrd Caflifghjkid Difbf Sfomcw E Dkvlw Sgshcvh Dt Tgnvrf Turin Italy
Kjoifcmw dxl Udnejfyomkwm Mghtodfd Aek Munich Germany
Ahwwqlg Uzitr Sxofpaqjv Luyelt De Btyzuik Bologna Italy
Faxveebbg Pjdl Lm Ieiwbbrpvvzgq Brwnqfvxl Dem Hpwrnvvv Upnuknohqgppz Lh Pff Madrid Spain
Uobtfbiopfszmuclfyhqv Wvqztcgri Amz Wuerzburg Germany
Uawjatidlziifijmvyeja Dwqqyziqhxi Azo Duesseldorf Germany
Ivcwf Oghekrov Abqezgczaq Sfx Lvlx Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
07.08.2025
Germany Germany
Recruiting
07.08.2025
Italy Italy
Recruiting
07.08.2025
Spain Spain
Recruiting
07.08.2025

Trial locations

Investigated drugs:

Baxdrostat is a new medication being studied for treating primary aldosteronism, a condition where the body produces too much of a hormone called aldosterone. This medication works by helping to control blood pressure in people who have this condition. It is being tested to see how well it works compared to a placebo and how safe it is for patients to use.

Investigated diseases:

Primary Aldosteronism – A hormonal disorder where the adrenal glands produce too much of the hormone aldosterone. This excess aldosterone causes the body to retain sodium and lose potassium, leading to an imbalance in these important minerals. The condition affects the body’s ability to regulate blood pressure and maintain proper fluid balance. Primary aldosteronism typically develops gradually and can cause high blood pressure that doesn’t respond well to standard blood pressure medications. The disorder can affect both kidneys and the body’s overall salt-water balance.

Trial ID:
2025-520740-16-00
Protocol code:
D6974C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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