NCT06168409CompletedPhase 3
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- First submitted
- 5 Dec 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 17 Aug 2025
- Lead sponsor
- AstraZeneca
- Diseases
- High blood pressure
- NCT number
- NCT06168409
- EU CT number
- 2023-507640-36-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 218
- From 1 Mar 2024 to the primary completion date, 17 Aug 2025
- 108 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Serum sodium level \< 135 mmol/L at Screening, as per central laboratory.
Other
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 110 mmHg.
- Persistent atrial fibrillation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lanús Este | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | San Vicente | Argentina | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| CHU Helora Coordinator of this site? Confirm its status | Mons | Belgium | Completed |
| Diagnostic Consultation Center XX-Sofia EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Kalimat Medical Center Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Hospital St. Anna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Research Site Coordinator of this site? Confirm its status | Cambridge | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | North Vancouver | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Terrebonne | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Innera s.r.o. Coordinator of this site? Confirm its status | Benešov | Czechia | Completed |
| MEDICUS SERVICES s.r.o. Coordinator of this site? Confirm its status | Brandýs nad Labem | Czechia | Completed |
| Edumed s.r.o. Coordinator of this site? Confirm its status | Broumov | Czechia | Completed |
| KardioBusak s.r.o. Coordinator of this site? Confirm its status | Louny | Czechia | Completed |
| Kardiologische Praxis Dr. med. univ. W. Jungmair Coordinator of this site? Confirm its status | Bad Homburg | Germany | Completed |
| Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH Coordinator of this site? Confirm its status | Elsterwerda | Germany | Completed |
| HELIOS Klinikum Erfurt GmbH Coordinator of this site? Confirm its status | Erfurt | Germany | Completed |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Kardiopraxis Schirmer Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Fundacio Hospital de l'Esperit Sant Coordinator of this site? Confirm its status | Santa Coloma de Gramenet | Spain | Completed |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Research Site Coordinator of this site? Confirm its status | Corby | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Prescot | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Swindon | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Thetford | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Weston-super-Mare | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Yate | United Kingdom | Unknown status |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Zugloi Egeszseguegyi Szolgalat Coordinator of this site? Confirm its status | Budapest XIV | Hungary | Completed |
| Studium Egeszseghaz Kft Coordinator of this site? Confirm its status | Kalocsa | Hungary | Completed |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| Da Vinci Spa Kft. Coordinator of this site? Confirm its status | Pecs | Hungary | Completed |
| KomplexLabor Kft. Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Research Site Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Muar town | Malaysia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sarawak Miri | Malaysia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Angeles City | Philippines | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Iloilo City | Philippines | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Nzoz Salusmed Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Research Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Nemocnica s poliklinikou Brezno, n.o. Coordinator of this site? Confirm its status | Brezno | Slovakia | Completed |
| Cardio D&R s.r.o. Kosice Coordinator of this site? Confirm its status | Košice | Slovakia | Completed |
| Interna SK s.r.o. Coordinator of this site? Confirm its status | Svidník | Slovakia | Completed |
| Research Site Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kinston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lake Worth | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lampasas | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Langhorne | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Port Charlotte | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Surprise | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hochiminh City | Vietnam | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kahramanmaraş | Turkey (Türkiye) | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Odunpazari | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.