nctId: NCT06344104 id: D6970C00008 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension acronym: BaxAsia overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2026-05-20 date: 2026-05-20 date: 2024-04-03 date: 2024-04-03 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian 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. conditions: Uncontrolled Hypertension conditions: Resistant Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: placebo control primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Baxdrostat name: Placebo measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from RWD baseline (Week 24) in siSBP at Week 32 measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Caba zip: C1426 country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Baotou zip: 014010 country: China lat: 40.65222 lon: 109.82222 facility: Research Site city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Bengbu zip: 233060 country: China lat: 32.94083 lon: 117.36083 facility: Research Site city: Changde zip: 415003 country: China lat: 29.04638 lon: 111.6783 facility: Research Site city: Changsha zip: 410015 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changsha zip: 430033 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changzhou zip: 272100 country: China lat: 31.77359 lon: 119.95401 facility: Research Site city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site city: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Chongqing zip: 400042 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Deyang zip: 618000 country: China lat: 31.13019 lon: 104.38198 facility: Research Site city: Guangzhou zip: 510100 country: China lat: 23.11667 lon: 113.25 facility: Research Site city: Ha'er Bin zip: 150001 country: China facility: Research Site city: Hangzhou zip: 310014 country: China lat: 30.29365 lon: 120.16142 facility: Research Site city: Hefei zip: 230601 country: China lat: 31.86389 lon: 117.28083 facility: Research Site city: Heze zip: 274099 country: China lat: 35.23929 lon: 115.47358 facility: Research Site city: Jiujiang zip: 332000 country: China lat: 29.70475 lon: 116.00206 facility: Research Site city: Luoyang zip: 471000 country: China lat: 34.68361 lon: 112.45361 facility: Research Site city: Meihekou zip: 135022 country: China lat: 42.52722 lon: 125.67528 facility: Research Site city: Nanchang zip: 330009 country: China lat: 28.68396 lon: 115.85306 facility: Research Site city: Nanchong zip: 637900 country: China lat: 30.79508 lon: 106.08473 facility: Research Site city: Nanjing zip: 210009 country: China lat: 32.06167 lon: 118.77778 facility: Research Site city: Ningbo zip: 315020 country: China lat: 29.87819 lon: 121.54945 facility: Research Site city: Panjin zip: 124009 country: China lat: 41.121 lon: 122.0739 facility: Research Site city: Puyang zip: 457000 country: China lat: 29.45679 lon: 119.88872 facility: Research Site city: Qiqihar zip: 161000 country: China lat: 47.34088 lon: 123.96045 facility: Research Site city: Sanya zip: 572000 country: China lat: 18.24306 lon: 109.505 facility: Research Site city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shenyang zip: 110004 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Shenyang zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Taiyuan zip: 030024 country: China lat: 37.86944 lon: 112.56028 facility: Research Site city: Tianjin zip: 300457 country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Wuhan zip: 430010 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Xianyang zip: 712000 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xianyang zip: 750004 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xuzhou zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: Research Site city: Yangzhou zip: 225001 country: China lat: 32.39722 lon: 119.43583 facility: Research Site city: Yinchuan zip: 750001 country: China lat: 38.46806 lon: 106.27306 facility: Research Site city: Zhengzhou country: China lat: 34.75778 lon: 113.64861 facility: Research Site city: Zigong zip: 643021 country: China lat: 29.34162 lon: 104.77689 facility: Research Site city: Hong Kong zip: 00000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong zip: 0000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: 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lon: 140.1 facility: Research Site city: Utsunomiya-shi zip: 320-8580 country: Japan lat: 36.56667 lon: 139.88333 facility: Research Site city: Yokohama-shi zip: 234-0054 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Daejeon zip: 35015 country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Research Site city: Seoul zip: 02841 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 04763 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 13620 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Iloilo City zip: 5000 country: Philippines lat: 10.69694 lon: 122.56444 facility: Research Site city: Quezon City zip: 1112 country: Philippines lat: 14.6488 lon: 121.0509 facility: Research Site city: St Petersburg zip: 197341 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Site city: Ankara zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site city: Hanoi zip: 100000 country: Vietnam lat: 21.0245 lon: 105.84117 facility: Research Site city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh zip: 70000 country: Vietnam hasResults: False