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: January 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

High Blood Pressure (Hypertension - Pediatric)

Diabetes And Hypertension

Williams Syndrome

Treatment

Baxdrostat

Placebo

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: 300
Treatment Group(s): 2
Primary Treatment: Baxdrostat
Phase: 3
Study Start date:
April 08, 2024
Estimated Completion Date:
May 20, 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

    Active - Recruiting

  • Research Site

    Caba, C1426
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad de Buenos Aires, C1419AHL
    Argentina

    Active - Recruiting

  • Research Site

    San Miguel de Tucuman, T4000ICL
    Argentina

    Active - Recruiting

  • Research Site

    San Nicolas de los Arroyos, B2900DPA
    Argentina

    Active - Recruiting

  • Research Site

    Coffs Harbour, 02450
    Australia

    Site Not Available

  • Research Site

    Gosford, 2250
    Australia

    Site Not Available

  • Research Site

    Hoppers Crossing, 3029
    Australia

    Site Not Available

  • Research Site

    Ipswich, 4305
    Australia

    Site Not Available

  • Research Site

    Margate, 33063
    Australia

    Site Not Available

  • Research Site

    Baotou, 014010
    China

    Active - Recruiting

  • Research Site

    Beijing, 100029
    China

    Active - Recruiting

  • Research Site

    Bengbu, 233060
    China

    Active - Recruiting

  • Research Site

    Changde, 415003
    China

    Active - Recruiting

  • Research Site

    Changsha, 410015
    China

    Active - Recruiting

  • Research Site

    Changzhou, 272100
    China

    Active - Recruiting

  • Research Site

    Chengdu, 610041
    China

    Active - Recruiting

  • Research Site

    Chongqing, 400014
    China

    Active - Recruiting

  • Research Site

    Deyang, 618000
    China

    Active - Recruiting

  • Research Site

    Guangzhou, 510100
    China

    Active - Recruiting

  • Research Site

    Ha'er Bin, 150001
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310014
    China

    Active - Recruiting

  • Research Site

    Hefei, 230601
    China

    Active - Recruiting

  • Research Site

    Heze, 274099
    China

    Active - Recruiting

  • Research Site

    Jiujiang, 332000
    China

    Active - Recruiting

  • Research Site

    Luoyang, 471000
    China

    Active - Recruiting

  • Research Site

    Meihekou, 135022
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330009
    China

    Active - Recruiting

  • Research Site

    Nanchong, 637900
    China

    Active - Recruiting

  • Research Site

    Nanjing, 210009
    China

    Active - Recruiting

  • Research Site

    Ningbo, 315020
    China

    Site Not Available

  • Research Site

    Panjin, 124009
    China

    Active - Recruiting

  • Research Site

    Puyang, 457000
    China

    Active - Recruiting

  • Research Site

    Qiqihar, 161000
    China

    Site Not Available

  • Research Site

    Sanya, 572000
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200040
    China

    Active - Recruiting

  • Research Site

    Shenyang, 110004
    China

    Active - Recruiting

  • Research Site

    Taiyuan, 030024
    China

    Site Not Available

  • Research Site

    Tianjin, 300457
    China

    Active - Recruiting

  • Research Site

    Wuhan, 430022
    China

    Active - Recruiting

  • Research Site

    Xianyang, 712000
    China

    Site Not Available

  • Research Site

    Xuzhou, 221000
    China

    Active - Recruiting

  • Research Site

    Yangzhou, 225001
    China

    Active - Recruiting

  • Research Site

    Yinchuan, 750001
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450052
    China

    Active - Recruiting

  • Research Site

    Zigong, 643021
    China

    Active - Recruiting

  • Research Site

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Research Site

    Bangalore, 560 092
    India

    Active - Recruiting

  • Research Site

    Belgaum, 590016
    India

    Active - Recruiting

  • Research Site

    Kanpur, 208002
    India

    Site Not Available

  • Research Site

    New Delhi, 110002
    India

    Site Not Available

  • Research Site

    Surat, 395001
    India

    Active - Recruiting

  • Research Site

    Chuo-ku, 103-0027
    Japan

    Active - Recruiting

  • Research Site

    Hamamatsu-shi, 430-0929
    Japan

    Active - Recruiting

  • Research Site

    Kagoshima-shi, 890-8520
    Japan

    Active - Recruiting

  • Research Site

    Koga-shi, 306-0232
    Japan

    Active - Recruiting

  • Research Site

    Meguro-ku, 153-0051
    Japan

    Active - Recruiting

  • Research Site

    Minato-ku, 108-0073
    Japan

    Active - Recruiting

  • Research Site

    Minokamo shi, 505-8510
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 530-8480
    Japan

    Active - Recruiting

  • Research Site

    Toshima-ku, 171-0014
    Japan

    Active - Recruiting

  • Research Site

    Tsukuba-shi, 305-0861
    Japan

    Active - Recruiting

  • Research Site

    Utsunomiya-shi, 320-8580
    Japan

    Completed

  • Research Site

    Yokohama-shi, 234-0054
    Japan

    Active - Recruiting

  • Research Site

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Iloilo City, 5000
    Philippines

    Active - Recruiting

  • Research Site

    Quezon City, 1112
    Philippines

    Active - Recruiting

  • Research Site

    Ivanovo, 153012
    Russian Federation

    Active - Recruiting

  • Research Site

    Moscow, 129327
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Petersburg, 195067
    Russian Federation

    Active - Recruiting

  • Research Site

    St Petersburg, 197341
    Russian Federation

    Active - Recruiting

  • Research Site

    Tver, 170036
    Russian Federation

    Site Not Available

  • Research Site

    Ankara, 5000
    Turkey

    Active - Recruiting

  • Research Site

    Edirne, 22030
    Turkey

    Active - Recruiting

  • Research Site

    Kahramanmaras, 46100
    Turkey

    Active - Recruiting

  • Research Site

    Karsiyaka, 35575
    Turkey

    Active - Recruiting

  • Research Site

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Research Site

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Research Site

    Mersin, 33343
    Turkey

    Active - Recruiting

  • Research Site

    Can Tho, 900000
    Vietnam

    Active - Recruiting

  • Research Site

    Da Nang, 55000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hochiminh, 70000
    Vietnam

    Active - Recruiting

  • Research Site

    Hochiminh city, 700000
    Vietnam

    Active - Recruiting

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