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
BaxAsia
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
1 other identifier
interventional
326
11 countries
93
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2026
CompletedApril 21, 2026
April 1, 2026
1.6 years
March 27, 2024
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in seated SBP at Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12
At Week 12
Secondary Outcomes (10)
Change from baseline in seated SBP at Week 12
At Week 12
Change from RWD baseline (Week 24) in seated SBP at Week 32
At Week 32
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
At Week 12
Change from baseline in seated DBP at Week 12
At Week 12
- +5 more secondary outcomes
Other Outcomes (1)
Number of participants with adverse events (AEs)
Up to week 54
Study Arms (3)
2 mg baxdrostat
EXPERIMENTAL2 mg baxdrostat administered orally, once daily (QD)
1 mg baxdrostat
EXPERIMENTAL1 mg baxdrostat administered orally, once daily (QD).
placebo
PLACEBO COMPARATORPlacebo administered orally, once daily (QD)
Interventions
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: * 1 mg per tablet for 1mg baxdrostat Arm * 2 mg per tablet for 2mg baxdrostat Arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (93)
Research Site
Bahía Blanca, 8000, Argentina
Research Site
CABA, C1426, Argentina
Research Site
Ciudad de Buenos Aires, C1419AHL, Argentina
Research Site
San Miguel de Tucumán, T4000ICL, Argentina
Research Site
San Nicolás de los Arroyos, B2900DPA, Argentina
Research Site
Coffs Harbour, 02450, Australia
Research Site
Gosford, 2250, Australia
Research Site
Hoppers Crossing, 3029, Australia
Research Site
Ipswich, 4305, Australia
Research Site
Baotou, 014010, China
Research Site
Beijing, 100029, China
Research Site
Beijing, 100044, China
Research Site
Bengbu, 233004, China
Research Site
Changde, 415000, China
Research Site
Changsha, 410015, China
Research Site
Changsha, 430033, China
Research Site
Changzhou, 272100, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400010, China
Research Site
Chongqing, 400014, China
Research Site
Chongqing, 400042, China
Research Site
Deyang, 618000, China
Research Site
Guangzhou, 510100, China
Research Site
Hangzhou, 310014, China
Research Site
Ha’erbin, 150001, China
Research Site
Hefei, 230601, China
Research Site
Heze, 274099, China
Research Site
Jiujiang, 332000, China
Research Site
Luoyang, 471000, China
Research Site
Meihekou, 135022, China
Research Site
Nanchang, 330009, China
Research Site
Nanchong, 637900, China
Research Site
Nanjing, 210009, China
Research Site
Panjin, 124009, China
Research Site
Sanya, 572000, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200040, China
Research Site
Shenyang, 110004, China
Research Site
Shenyang, 110016, China
Research Site
Taiyuan, 030024, China
Research Site
Tianjin, 300457, China
Research Site
Tianjin, China
Research Site
Wuhan, 430010, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430060, China
Research Site
Xianyang, 712000, China
Research Site
Xianyang, 750004, China
Research Site
Xuzhou, 221000, China
Research Site
Yangzhou, 225001, China
Research Site
Yinchuan, 750001, China
Research Site
Zigong, 643021, China
Research Site
Hong Kong, 00000, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Bangalore, 560 092, India
Research Site
Belagavi, 590016, India
Research Site
Chūōku, 103-0027, Japan
Research Site
Chūōku, 260-0804, Japan
Research Site
Hamamatsu, 430-0929, Japan
Research Site
Kagoshima, 890-8520, Japan
Research Site
Koga-shi, 306-0232, Japan
Research Site
Meguro-ku, 153-0051, Japan
Research Site
Minatoku, 108-0073, Japan
Research Site
Minokamo Shi, 505-8510, Japan
Research Site
Osaka, 530-8480, Japan
Research Site
Toshima-ku, 171-0014, Japan
Research Site
Tsukuba, 305-0861, Japan
Research Site
Yokohama, 236-0004, Japan
Research Site
Iloilo City, 5000, Philippines
Research Site
Quezon City, 1112, Philippines
Research Site
Ivanovo, 153012, Russia
Research Site
Moscow, 111539, Russia
Research Site
Moscow, 119991, Russia
Research Site
Moscow, 121552, Russia
Research Site
Moscow, 129327, Russia
Research Site
Saint Petersburg, 195067, Russia
Research Site
Saint Petersburg, 197341, Russia
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 04763, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Ankara, 06800, Turkey (Türkiye)
Research Site
Ankara, 5000, Turkey (Türkiye)
Research Site
Cordaleo, 35575, Turkey (Türkiye)
Research Site
Edirne, 22030, Turkey (Türkiye)
Research Site
Kahramanmaraş, 46100, Turkey (Türkiye)
Research Site
Kayseri, 38039, Turkey (Türkiye)
Research Site
Kocaeli, 41380, Turkey (Türkiye)
Research Site
Mersin, 33343, Turkey (Türkiye)
Research Site
Can Tho, 900000, Vietnam
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Hochiminh City, 700000, Vietnam
Research Site
Hochiminh, 70000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 3, 2024
Study Start
April 8, 2024
Primary Completion
November 24, 2025
Study Completion
April 3, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.