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New drug aimed at stubborn high blood pressure passes final trial phase

NCT ID NCT06168409

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This Phase 3 trial tested a once-daily pill called baxdrostat in 218 adults with resistant hypertension—high blood pressure that stays high despite taking three or more medications. Participants received either baxdrostat or a placebo for 12 weeks. The main goal was to see if baxdrostat could lower average blood pressure over 24 hours better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baxdrostat (a tablet taken once daily)
What this could lead to
If successful, baxdrostat could offer a new daily pill option for people whose high blood pressure is not controlled by multiple existing medications.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not lower blood pressure enough to be meaningful, or side effects could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

218 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be ≥ 18 years old, at the time of signing the informed consent. * Mean seated SBP on AOBPM of ≥ 140 mmHg and \< 170 mmHg at Screening. * Have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study. * Have eGFR ≥ 45 mL/min/1.73 m2 at Screening. * Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening, determined as per central laboratory * Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation. Exclusion Criteria: * Mean seated SBP on AOBPM ≥ 170 mmHg. * Mean seated DBP on AOBPM ≥ 110 mmHg. * Serum sodium level \< 135 mmol/L at Screening, as per central laboratory. * Participant has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation. * New York Heart Association functional HF class IV. * Persistent atrial fibrillation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Surprise, Arizona, 85374, United States

  • Research Site

    Hollywood, Florida, 33024, United States

  • Research Site

    Lake Worth, Florida, 33467, United States

  • Research Site

    Port Charlotte, Florida, 33952, United States

  • Research Site

    Fort Wayne, Indiana, 46804, United States

  • Research Site

    Lexington, Kentucky, 40503, United States

  • Research Site

    The Bronx, New York, 10455, United States

  • Research Site

    Greenville, North Carolina, 27834, United States

  • Research Site

    Jacksonville, North Carolina, 28546, United States

  • Research Site

    Kinston, North Carolina, 28504, United States

  • Research Site

    New Bern, North Carolina, 28562, United States

  • Research Site

    Wilmington, North Carolina, 28401, United States

  • Research Site

    Langhorne, Pennsylvania, 19047, United States

  • Research Site

    Brownsville, Texas, 78526, United States

  • Research Site

    Corpus Christi, Texas, 78404, United States

  • Research Site

    Lampasas, Texas, 76550, United States

  • Research Site

    CABA, C1061, Argentina

  • Research Site

    CABA, C1425HFA, Argentina

  • Research Site

    Capital Federal, C1060ABN, Argentina

  • Research Site

    Córdoba, X5003DCP, Argentina

  • Research Site

    Lanús Este, B1824KAJ, Argentina

  • Research Site

    Rosario, S2000PBJ, Argentina

  • Research Site

    San Miguel de Tucumán, 4000, Argentina

  • Research Site

    San Vicente, 5006, Argentina

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Perth, 6000, Australia

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Sofia, 1527, Bulgaria

  • Research Site

    Sofia, 1618, Bulgaria

  • Research Site

    Sofia, 1680, Bulgaria

  • Research Site

    Edmonton, Alberta, T6G 2C8, Canada

  • Research Site

    North Vancouver, British Columbia, V7M 2H4, Canada

  • Research Site

    Cambridge, Ontario, N1R 6V6, Canada

  • Research Site

    Toronto, Ontario, M6G 1M2, Canada

  • Research Site

    Waterloo, Ontario, N2T 0C1, Canada

  • Research Site

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Research Site

    Terrebonne, Quebec, J6X 4P7, Canada

  • Research Site

    Benešov, 256 01, Czechia

  • Research Site

    Brandýs nad Labem, 250 01, Czechia

  • Research Site

    Broumov, 55001, Czechia

  • Research Site

    Louny, 440 01, Czechia

  • Research Site

    Bad Homburg, 61348, Germany

  • Research Site

    Berlin, 12203, Germany

  • Research Site

    Frankfurt, 60590, Germany

  • Research Site

    Kaiserslautern, 67655, Germany

  • Research Site

    Athens, 11527, Greece

  • Research Site

    Attica, 11527, Greece

  • Research Site

    Thessaloniki, 54642, Greece

  • Research Site

    Budapest, 1115, Hungary

  • Research Site

    Budapest, 1148, Hungary

  • Research Site

    Kalocsa, 6300, Hungary

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Pécs, 7635, Hungary

  • Research Site

    Kota Bharu, 15586, Malaysia

  • Research Site

    Muar town, 84000, Malaysia

  • Research Site

    Sarawak Miri, 98000, Malaysia

  • Research Site

    Angeles City, 2009, Philippines

  • Research Site

    Iloilo City, 5000, Philippines

  • Research Site

    Bialystok, 15-540, Poland

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Krakow, 30-688, Poland

  • Research Site

    Lodz, 91-002, Poland

  • Research Site

    Poznan, 61-848, Poland

  • Research Site

    Warsaw, 04-628, Poland

  • Research Site

    Riyadh, 11426, Saudi Arabia

  • Research Site

    Riyadh, 11462, Saudi Arabia

  • Research Site

    Brezno, 977 01, Slovakia

  • Research Site

    Košice, 04022, Slovakia

  • Research Site

    Svidník, 08901, Slovakia

  • Research Site

    Cape Town, 7500, South Africa

  • Research Site

    Durban, 4001, South Africa

  • Research Site

    Barcelona, 08003, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Santa Coloma de Gramenet, 08923, Spain

  • Research Site

    Terrassa (Barcelona), 08221, Spain

  • Research Site

    Valencia, 46010, Spain

  • Research Site

    New Taipei City, 220, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Adana, 01060, Turkey (Türkiye)

  • Research Site

    Ankara, 06230, Turkey (Türkiye)

  • Research Site

    Kahramanmaraş, 46100, Turkey (Türkiye)

  • Research Site

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    Odunpazari, 26080, Turkey (Türkiye)

  • Research Site

    Corby, NN17 2UR, United Kingdom

  • Research Site

    London, E1 1BB, United Kingdom

  • Research Site

    London, W6 7HY, United Kingdom

  • Research Site

    Prescot, L35 5DR, United Kingdom

  • Research Site

    Swindon, SN3 6BB, United Kingdom

  • Research Site

    Thetford, IP24 1JD, United Kingdom

  • Research Site

    Weston-super-Mare, BS24 7PR, United Kingdom

  • Research Site

    Yate, BS37 4AX, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hochiminh City, 700000, Vietnam

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