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

Last updated: March 26, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Stress

Vascular Diseases

High Blood Pressure (Hypertension - Pediatric)

Treatment

Placebo

Baxdrostat

Clinical Study ID

NCT06344104
D6970C00008
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants must be ≥ 18 years old.

  • Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg atScreening.

  • Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensivemedications, from different therapeutic classes (at least one must be adiuretic), at maximum tolerated dose in the judgement of the Investigator.

  2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensivemedications, from different therapeutic classes (at least one must be adiuretic), 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 onAOBPM ≥ 135 mmHg at Baseline.

Exclusion

Exclusion Criteria:

  • Mean seated SBP on AOBPM ≥ 170 mmHg.

  • Mean seated DBP on AOBPM ≥ 105 mmHg.

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

  • 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.

Study Design

Total Participants: 326
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 08, 2024
Estimated Completion Date:
April 03, 2026

Study Description

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Connect with a study center

  • Research Site

    Bahia Blanca, 8000
    Argentina

    Site Not Available

  • Research Site

    Bahía Blanca, 8000
    Argentina

    Site Not Available

  • Research Site

    Bahía Blanca 3865086, 8000
    Argentina

    Site Not Available

  • Research Site

    CABA, C1426
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, C1419AHL
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucuman, T4000ICL
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucumán, T4000ICL
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucumán 3836873, T4000ICL
    Argentina

    Site Not Available

  • Research Site

    San Nicolas de los Arroyos, B2900DPA
    Argentina

    Site Not Available

  • Research Site

    San Nicolás de los Arroyos, B2900DPA
    Argentina

    Site Not Available

  • Research Site

    San Nicolás de los Arroyos 3836846, B2900DPA
    Argentina

    Site Not Available

  • Research Site

    Coffs Harbour, 02450
    Australia

    Site Not Available

  • Research Site

    Coffs Harbour 2171085, 02450
    Australia

    Site Not Available

  • Research Site

    Gosford, 2250
    Australia

    Site Not Available

  • Research Site

    Gosford 2164849, 2250
    Australia

    Site Not Available

  • Research Site

    Hoppers Crossing, 3029
    Australia

    Site Not Available

  • Research Site

    Hoppers Crossing 7281807, 3029
    Australia

    Site Not Available

  • Research Site

    Ipswich, 4305
    Australia

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  • Research Site

    Ipswich 2162644, 4305
    Australia

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  • Research Site

    Margate, 33063
    Australia

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  • Research Site

    Baotou, 014010
    China

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  • Research Site

    Baotou 2038432, 014010
    China

    Site Not Available

  • Research Site

    Beijing, 100044
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100044
    China

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  • Research Site

    Bengbu, 233004
    China

    Site Not Available

  • Research Site

    Bengbu 1816440, 233004
    China

    Site Not Available

  • Research Site

    Changde, 415000
    China

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  • Research Site

    Changde 1791121, 415000
    China

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  • Research Site

    Changsha, 410015
    China

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  • Research Site

    Changsha 1815577, 410015
    China

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  • Research Site

    Changzhou, 272100
    China

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  • Research Site

    Changzhou 1815456, 272100
    China

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  • Research Site

    Chengdu, 610041
    China

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  • Research Site

    Chengdu 1815286, 610041
    China

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    Chongqing, 400014
    China

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  • Research Site

    Chongqing 1814906, 400042
    China

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  • Research Site

    Deyang, 618000
    China

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  • Research Site

    Deyang 1812961, 618000
    China

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    Guangzhou, 510100
    China

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  • Research Site

    Guangzhou 1809858, 510100
    China

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  • Research Site

    Ha'er Bin, 150001
    China

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    Hangzhou, 310014
    China

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  • Research Site

    Hangzhou 1808926, 310014
    China

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    Ha’erbin, 150001
    China

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  • Research Site

    Ha’erbin 10202737, 150001
    China

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  • Research Site

    Hefei, 230601
    China

    Site Not Available

  • Research Site

    Hefei 1808722, 230601
    China

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  • Research Site

    Heze, 274099
    China

    Site Not Available

  • Research Site

    Heze 1808198, 274099
    China

    Site Not Available

  • Research Site

    Jiujiang, 332000
    China

    Site Not Available

  • Research Site

    Jiujiang 1805179, 332000
    China

    Site Not Available

  • Research Site

    Luoyang, 471000
    China

    Site Not Available

  • Research Site

    Luoyang 1801792, 471000
    China

    Site Not Available

  • Research Site

    Meihekou, 135022
    China

    Site Not Available

  • Research Site

    Meihekou 2035801, 135022
    China

    Site Not Available

  • Research Site

    Nanchang, 330009
    China

    Site Not Available

  • Research Site

    Nanchang 1800163, 330009
    China

    Site Not Available

  • Research Site

    Nanchong, 637900
    China

    Site Not Available

  • Research Site

    Nanchong 1800146, 637900
    China

    Site Not Available

  • Research Site

    Nanjing, 210009
    China

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  • Research Site

    Nanjing 1799962, 210009
    China

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  • Research Site

    Ningbo, 315020
    China

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  • Research Site

    Panjin, 124009
    China

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  • Research Site

    Panjin 10794003, 124009
    China

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  • Research Site

    Puyang, 457000
    China

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  • Research Site

    Qiqihar, 161000
    China

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  • Research Site

    Sanya, 572000
    China

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  • Research Site

    Sanya 1796556, 572000
    China

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    Shanghai, 200025
    China

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  • Research Site

    Shanghai 1796236, 200025
    China

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  • Research Site

    Shenyang, 110004
    China

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  • Research Site

    Shenyang 2034937, 110004
    China

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    Taiyuan, 030024
    China

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  • Research Site

    Taiyuan 1793511, 030024
    China

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  • Research Site

    Tianjin, 300457
    China

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  • Research Site

    Tianjin 1792947,
    China

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    Wuhan, 430010
    China

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  • Research Site

    Wuhan 1791247, 430060
    China

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  • Research Site

    Xianyang, 712000
    China

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  • Research Site

    Xianyang 1790353, 712000
    China

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  • Research Site

    Xuzhou, 221000
    China

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  • Research Site

    Xuzhou 10630003, 221000
    China

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  • Research Site

    Yangzhou, 225001
    China

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  • Research Site

    Yangzhou 1787227, 225001
    China

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  • Research Site

    Yinchuan, 750001
    China

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  • Research Site

    Yinchuan 1786657, 750001
    China

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    Zhengzhou, 450052
    China

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  • Research Site

    Zigong, 643021
    China

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  • Research Site

    Zigong 1783745, 643021
    China

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    Hong Kong, 00000
    Hong Kong

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    Hong Kong 1819729,
    Hong Kong

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    Bangalore, 560 092
    India

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  • Research Site

    Bangalore 1277333, 560 092
    India

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  • Research Site

    Belagavi, 590016
    India

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  • Research Site

    Belagavi 1276533, 590016
    India

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  • Research Site

    Belgaum, 590016
    India

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  • Research Site

    Kanpur, 208002
    India

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    New Delhi, 110002
    India

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    Surat, 395001
    India

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    Chuo-ku, 103-0027
    Japan

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  • Research Site

    Chūōku, 260-0804
    Japan

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  • Research Site

    Chūōku 10262791, 260-0804
    Japan

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  • Research Site

    Hamamatsu, 430-0929
    Japan

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  • Research Site

    Hamamatsu 1863289, 430-0929
    Japan

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  • Research Site

    Hamamatsu-shi, 430-0929
    Japan

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  • Research Site

    Kagoshima, 890-8520
    Japan

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  • Research Site

    Kagoshima 1860827, 890-8520
    Japan

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  • Research Site

    Kagoshima-shi, 890-8520
    Japan

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  • Research Site

    Koga-shi, 306-0232
    Japan

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  • Research Site

    Meguro-ku, 153-0051
    Japan

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  • Research Site

    Minato-ku, 108-0073
    Japan

    Site Not Available

  • Research Site

    Minatoku, 108-0073
    Japan

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  • Research Site

    Minatoku 11191118, 108-0073
    Japan

    Site Not Available

  • Research Site

    Minokamo Shi, 505-8510
    Japan

    Site Not Available

  • Research Site

    Minokamo shi, 505-0010
    Japan

    Site Not Available

  • Research Site

    Osaka, 530-8480
    Japan

    Site Not Available

  • Research Site

    Osaka 1853909, 530-8480
    Japan

    Site Not Available

  • Research Site

    Osaka-shi, 530-8480
    Japan

    Site Not Available

  • Research Site

    Toshima-ku, 171-0014
    Japan

    Site Not Available

  • Research Site

    Tsukuba, 305-0861
    Japan

    Site Not Available

  • Research Site

    Tsukuba 2110681, 305-0861
    Japan

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  • Research Site

    Tsukuba-shi, 305-0861
    Japan

    Site Not Available

  • Research Site

    Utsunomiya-shi, 320-8580
    Japan

    Site Not Available

  • Research Site

    Yokohama, 236-0004
    Japan

    Site Not Available

  • Research Site

    Yokohama 1848354, 236-0004
    Japan

    Site Not Available

  • Research Site

    Yokohama-shi, 234-0054
    Japan

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  • Research Site

    Daejeon, 35015
    Korea, Republic of

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  • Research Site

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Research Site

    Iloilo City, 5000
    Philippines

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  • Research Site

    Iloilo City 1711005, 5000
    Philippines

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  • Research Site

    Quezon City, 1112
    Philippines

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  • Research Site

    Quezon City 1692192, 1112
    Philippines

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  • Research Site

    Ivanovo, 153012
    Russia

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  • Research Site

    Ivanovo 555312, 153012
    Russia

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  • Research Site

    Moscow, 111539
    Russia

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  • Research Site

    Moscow 524901, 111539
    Russia

    Site Not Available

  • Research Site

    Saint Petersburg, 197341
    Russia

    Site Not Available

  • Research Site

    Saint Petersburg 498817, 195067
    Russia

    Site Not Available

  • Research Site

    Ivanovo, 153012
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, 129327
    Russian Federation

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  • Research Site

    Saint-Petersburg, 194354
    Russian Federation

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  • Research Site

    St Petersburg, 197341
    Russian Federation

    Site Not Available

  • Research Site

    Tver, 170036
    Russian Federation

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  • Research Site

    Seoul, 04763
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Research Site

    Ankara, 5000
    Turkey

    Site Not Available

  • Research Site

    Edirne, 22030
    Turkey

    Site Not Available

  • Research Site

    Kahramanmaras, 46100
    Turkey

    Site Not Available

  • Research Site

    Karsiyaka, 35575
    Turkey

    Site Not Available

  • Research Site

    Kayseri, 38039
    Turkey

    Site Not Available

  • Research Site

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Research Site

    Mersin, 33343
    Turkey

    Site Not Available

  • Research Site

    Ankara, 5000
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Ankara 323786, 06800
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Cordaleo, 35575
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Edirne, 22030
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Edirne 747712, 22030
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kahramanmaraş, 46100
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kahramanmaraş 310859, 46100
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Karşıyaka 747912, 35575
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kayseri, 38039
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kayseri 308464, 38039
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kocaeli, 41380
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kocaeli 306970, 41380
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Mersin, 33343
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Mersin 304531, 33343
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Can Tho, 900000
    Vietnam

    Site Not Available

  • Research Site

    Can Tho 1586203, 900000
    Vietnam

    Site Not Available

  • Research Site

    Da Nang, 55000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

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  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hochiminh, 70000
    Vietnam

    Site Not Available

  • Research Site

    Hochiminh City, 700000
    Vietnam

    Site Not Available

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