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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
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

Full criteria on ClinicalTrials.gov

Sites (108)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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CABAArgentinaUnknown status
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Capital FederalArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Lanús EsteArgentinaUnknown status
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RosarioArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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San VicenteArgentinaUnknown status
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ClaytonAustraliaUnknown status
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PerthAustraliaUnknown status
Az Maria Middelares Gent
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GentBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
CHU Helora
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MonsBelgiumCompleted
Diagnostic Consultation Center XX-Sofia EOOD
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SofiaBulgariaCompleted
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaCompleted
Kalimat Medical Center Ltd.
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SofiaBulgariaCompleted
University Hospital St. Anna
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SofiyaBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
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CambridgeCanadaUnknown status
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ChicoutimiCanadaUnknown status
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EdmontonCanadaUnknown status
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North VancouverCanadaUnknown status
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TerrebonneCanadaUnknown status
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TorontoCanadaUnknown status
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WaterlooCanadaUnknown status
Innera s.r.o.
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BenešovCzechiaCompleted
MEDICUS SERVICES s.r.o.
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Brandýs nad LabemCzechiaCompleted
Edumed s.r.o.
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BroumovCzechiaCompleted
KardioBusak s.r.o.
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LounyCzechiaCompleted
Kardiologische Praxis Dr. med. univ. W. Jungmair
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Bad HomburgGermanyCompleted
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad OeynhausenGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Zentrum fuer klinische Studien Suedbrandenburg GmbH
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ElsterwerdaGermanyCompleted
HELIOS Klinikum Erfurt GmbH
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ErfurtGermanyCompleted
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyCompleted
Kardiopraxis Schirmer
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KaiserslauternGermanyCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Fundacio Hospital de l'Esperit Sant
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Santa Coloma de GramenetSpainCompleted
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
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CorbyUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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PrescotUnited KingdomUnknown status
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SwindonUnited KingdomUnknown status
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ThetfordUnited KingdomUnknown status
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Weston-super-MareUnited KingdomUnknown status
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YateUnited KingdomUnknown status
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
Hippokration Hospital
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AthensGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
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BudapestHungaryCompleted
Zugloi Egeszseguegyi Szolgalat
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Budapest XIVHungaryCompleted
Studium Egeszseghaz Kft
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KalocsaHungaryCompleted
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryCompleted
Da Vinci Spa Kft.
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PecsHungaryCompleted
KomplexLabor Kft.
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SzegedHungaryCompleted
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Kota BharuMalaysiaUnknown status
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Muar townMalaysiaUnknown status
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Sarawak MiriMalaysiaUnknown status
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Angeles CityPhilippinesUnknown status
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Iloilo CityPhilippinesUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Nzoz Salusmed
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
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RiyadhSaudi ArabiaUnknown status
Nemocnica s poliklinikou Brezno, n.o.
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BreznoSlovakiaCompleted
Cardio D&R s.r.o. Kosice
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KošiceSlovakiaCompleted
Interna SK s.r.o.
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SvidníkSlovakiaCompleted
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BangkokThailandUnknown status
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Chiang MaiThailandUnknown status
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Khon KaenThailandUnknown status
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New Taipei CityTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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BrownsvilleUnited StatesUnknown status
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Corpus ChristiUnited StatesUnknown status
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Fort WayneUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HollywoodUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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KinstonUnited StatesUnknown status
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Lake WorthUnited StatesUnknown status
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LampasasUnited StatesUnknown status
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LanghorneUnited StatesUnknown status
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LexingtonUnited StatesUnknown status
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New BernUnited StatesUnknown status
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Port CharlotteUnited StatesUnknown status
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SurpriseUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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WilmingtonUnited StatesUnknown status
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HanoiVietnamUnknown status
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Hochiminh CityVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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Cape TownSouth AfricaUnknown status
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DurbanSouth AfricaUnknown status
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AdanaTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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KahramanmaraşTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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OdunpazariTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.