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NCT06344104CompletedPhase 3

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
326 (actual)
First submitted
27 Mar 2024
Start date
8 Apr 2024
Primary completion date
24 Nov 2025
Lead sponsor
AstraZeneca
NCT number
NCT06344104

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 326
  • From 8 Apr 2024 to the primary completion date, 24 Nov 2025
  • 73 sites in 11 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

  • 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.
  • NYHA functional heart failure class IV at Screening.

Lab values

  • Serum sodium level (Na+) \< 135 mmol/L at Screening.

Other

  • Mean seated SBP on AOBPM ≥ 170 mmHg.
  • Mean seated DBP on AOBPM ≥ 105 mmHg.

Who the study is looking for

  • Male or female participants must be ≥ 18 years old.
  • Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
  • Fulfil at least 1 of the following 2 criteria:
    • uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
    • rHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
  • Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Bahía BlancaArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad de Buenos AiresArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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San Nicolás de los ArroyosArgentinaUnknown status
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Coffs HarbourAustraliaUnknown status
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GosfordAustraliaUnknown status
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Hoppers CrossingAustraliaUnknown status
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IpswichAustraliaUnknown status
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BaotouChinaUnknown status
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BeijingChinaUnknown status
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BengbuChinaUnknown status
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ChangdeChinaUnknown status
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ChangshaChinaUnknown status
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ChangzhouChinaUnknown status
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ChengduChinaUnknown status
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ChongqingChinaUnknown status
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DeyangChinaUnknown status
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GuangzhouChinaUnknown status
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Ha’erbinChinaUnknown status
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HangzhouChinaUnknown status
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HefeiChinaUnknown status
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HezeChinaUnknown status
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JiujiangChinaUnknown status
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LuoyangChinaUnknown status
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MeihekouChinaUnknown status
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NanchangChinaUnknown status
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NanchongChinaUnknown status
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NanjingChinaUnknown status
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PanjinChinaUnknown status
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SanyaChinaUnknown status
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ShanghaiChinaUnknown status
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ShenyangChinaUnknown status
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TaiyuanChinaUnknown status
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TianjinChinaUnknown status
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WuhanChinaUnknown status
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XianyangChinaUnknown status
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XuzhouChinaUnknown status
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YangzhouChinaUnknown status
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YinchuanChinaUnknown status
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ZigongChinaUnknown status
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Hong KongHong KongUnknown status
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BangaloreIndiaUnknown status
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BelagaviIndiaUnknown status
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ChūōkuJapanUnknown status
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HamamatsuJapanUnknown status
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KagoshimaJapanUnknown status
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Koga-shiJapanUnknown status
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Meguro-kuJapanUnknown status
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MinatokuJapanUnknown status
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Minokamo ShiJapanUnknown status
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OsakaJapanUnknown status
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Toshima-kuJapanUnknown status
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TsukubaJapanUnknown status
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YokohamaJapanUnknown status
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SeoulSouth KoreaUnknown status
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Iloilo CityPhilippinesUnknown status
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Quezon CityPhilippinesUnknown status
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IvanovoRussiaUnknown status
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MoscowRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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Can ThoVietnamUnknown status
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HanoiVietnamUnknown status
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HochiminhVietnamUnknown status
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Hochiminh CityVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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CordaleoTurkey (Türkiye)Unknown status
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EdirneTurkey (Türkiye)Unknown status
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KahramanmaraşTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status
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MersinTurkey (Türkiye)Unknown status

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