A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
NCT ID: NCT06168409
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2024-03-01
2025-08-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimum Treatment for Drug-Resistant Hypertension
NCT02369081
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
NCT06205628
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
NCT00272961
VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION
NCT04388124
Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
NCT00362115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:
• 2 mg per tablet.
Placebo
Placebo administered orally, once daily (QD)
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:
• 2 mg per tablet.
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Surprise, Arizona, United States
Research Site
Hollywood, Florida, United States
Research Site
Lake Worth, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Lexington, Kentucky, United States
Research Site
The Bronx, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Jacksonville, North Carolina, United States
Research Site
Kinston, North Carolina, United States
Research Site
New Bern, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Langhorne, Pennsylvania, United States
Research Site
Brownsville, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Lampasas, Texas, United States
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
Capital Federal, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Lanús Este, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
San Vicente, , Argentina
Research Site
Clayton, , Australia
Research Site
Perth, , Australia
Research Site
Ghent, , Belgium
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Edmonton, Alberta, Canada
Research Site
North Vancouver, British Columbia, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Terrebonne, Quebec, Canada
Research Site
Benešov, , Czechia
Research Site
Brandýs nad Labem, , Czechia
Research Site
Broumov, , Czechia
Research Site
Louny, , Czechia
Research Site
Bad Homburg, , Germany
Research Site
Berlin, , Germany
Research Site
Frankfurt, , Germany
Research Site
Kaiserslautern, , Germany
Research Site
Athens, , Greece
Research Site
Attica, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Kalocsa, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Pécs, , Hungary
Research Site
Kota Bharu, , Malaysia
Research Site
Muar town, , Malaysia
Research Site
Sarawak Miri, , Malaysia
Research Site
Angeles City, , Philippines
Research Site
Iloilo City, , Philippines
Research Site
Bialystok, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Research Site
Riyadh, , Saudi Arabia
Research Site
Riyadh, , Saudi Arabia
Research Site
Brezno, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Svidník, , Slovakia
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Santa Coloma de Gramenet, , Spain
Research Site
Terrassa (Barcelona), , Spain
Research Site
Valencia, , Spain
Research Site
New Taipei City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Muang, , Thailand
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Kahramanmaraş, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Odunpazari, , Turkey (Türkiye)
Research Site
Corby, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Prescot, , United Kingdom
Research Site
Swindon, , United Kingdom
Research Site
Thetford, , United Kingdom
Research Site
Weston-super-Mare, , United Kingdom
Research Site
Yate, , United Kingdom
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Hochiminh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-507640-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D6970C00009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.