protocolSection identificationModule nctId: NCT06344104, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2026-05-20, completionDateStruct date: 2026-05-20, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Uncontrolled Hypertension, conditions: Resistant Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: placebo control, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Baxdrostat, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from RWD baseline (Week 24) in siSBP at Week 32, secondaryOutcomes measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM, secondaryOutcomes measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM, secondaryOutcomes measure: Change from baseline in siDBP at Week 12, secondaryOutcomes measure: Achieving siSBP < 140 mmHg at Week 12, secondaryOutcomes measure: Change from baseline in siDBP at Week 12, secondaryOutcomes measure: Achieving siSBP < 140 mmHg at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, otherOutcomes measure: Number of participants with adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Caba, zip: C1426, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Baotou, zip: 014010, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Research Site, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Beijing, zip: 100044, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Bengbu, zip: 233060, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Research Site, city: Changde, zip: 415003, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Research Site, city: Changsha, zip: 410015, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, city: Changsha, zip: 430033, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, city: Changzhou, zip: 272100, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Research Site, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, city: Chongqing, zip: 400010, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, city: Chongqing, zip: 400042, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, city: Deyang, zip: 618000, country: China, geoPoint lat: 31.13019, lon: 104.38198, locations facility: Research Site, city: Guangzhou, zip: 510100, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, city: Ha'er Bin, zip: 150001, country: China, locations facility: Research Site, city: Hangzhou, zip: 310014, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, city: Hefei, zip: 230601, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Research Site, city: Heze, zip: 274099, country: China, geoPoint lat: 35.23929, lon: 115.47358, locations facility: Research Site, city: Jiujiang, zip: 332000, country: China, geoPoint lat: 29.70475, lon: 116.00206, locations facility: Research Site, city: Luoyang, zip: 471000, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Research Site, city: Meihekou, zip: 135022, country: China, geoPoint lat: 42.52722, lon: 125.67528, locations facility: Research Site, city: Nanchang, zip: 330009, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, city: Nanchong, zip: 637900, country: China, geoPoint lat: 30.79508, lon: 106.08473, locations facility: Research Site, city: Nanjing, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, city: Ningbo, zip: 315020, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Research Site, city: Panjin, zip: 124009, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: Research Site, city: Puyang, zip: 457000, country: China, geoPoint lat: 29.45679, lon: 119.88872, locations facility: Research Site, city: Qiqihar, zip: 161000, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: Research Site, city: Sanya, zip: 572000, country: China, geoPoint lat: 18.24306, lon: 109.505, locations facility: Research Site, city: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, city: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, city: Shenyang, zip: 110004, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, city: Shenyang, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, city: Taiyuan, zip: 030024, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Research Site, city: Tianjin, zip: 300457, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, city: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, city: Wuhan, zip: 430010, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Wuhan, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Wuhan, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Xianyang, zip: 712000, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Research Site, city: Xianyang, zip: 750004, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Research Site, city: Xuzhou, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, city: Yangzhou, zip: 225001, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Research Site, city: Yinchuan, zip: 750001, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, city: Zhengzhou, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, city: Zigong, zip: 643021, country: China, geoPoint lat: 29.34162, lon: 104.77689, locations facility: Research Site, city: Hong Kong, zip: 00000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Hong Kong, zip: 0000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Bangalore, zip: 560 092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Research Site, city: Belgaum, zip: 590016, country: India, geoPoint lat: 15.85212, lon: 74.50447, locations facility: Research Site, city: Kanpur, zip: 208002, country: India, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Research Site, city: New Delhi, zip: 110002, country: India, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Research Site, city: New Delhi, zip: 110060, country: India, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Research Site, city: Surat, zip: 395001, country: India, geoPoint lat: 21.19594, lon: 72.83023, locations facility: Research Site, city: Chuo-ku, zip: 103-0027, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, city: Chuo-ku, zip: 260-0804, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, city: Kagoshima-shi, zip: 890-8520, country: Japan, geoPoint lat: 31.56667, lon: 130.55, locations facility: Research Site, city: Minato-ku, zip: 108-0073, country: Japan, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Research Site, city: Tsukuba-shi, zip: 305-0861, country: Japan, geoPoint lat: 36.2, lon: 140.1, locations facility: Research Site, city: Utsunomiya-shi, zip: 320-8580, country: Japan, geoPoint lat: 36.56667, lon: 139.88333, locations facility: Research Site, city: Yokohama-shi, zip: 234-0054, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, city: Yokohama-shi, zip: 236-0004, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, city: Daejeon, zip: 35015, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Research Site, city: Seoul, zip: 02841, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 04763, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Iloilo City, zip: 5000, country: Philippines, geoPoint lat: 10.69694, lon: 122.56444, locations facility: Research Site, city: Quezon City, zip: 1112, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, city: St Petersburg, zip: 197341, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Site, city: Ankara, zip: 06800, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, city: Kahramanmaras, zip: 46100, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, locations facility: Research Site, city: Kayseri, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, locations facility: Research Site, city: Kocaeli, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Research Site, city: Hanoi, zip: 100000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Research Site, city: Ho Chi Minh, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, city: Hochiminh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, city: Hochiminh, zip: 70000, country: Vietnam, hasResults: False