Uncontrolled HypertensionPhase 3BaxAsiaNCT06344104
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
A Phase 3 study testing Baxdrostat in people with Uncontrolled Hypertension and Resistant Hypertension, run by AstraZeneca at 93 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension, Resistant Hypertension
- What is being tested?
- Baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 93 sitesin 11 countries
- Study dates
- 8 Apr 2024to 3 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
93 sites in 11 countries.
93 sites in 11 countries
China42 sites
Research Site
Baotou, 014010
Research Site
Beijing, 100029
Research Site
Beijing, 100044
Research Site
Bengbu, 233004
Research Site
Changde, 415000
Research Site
Changsha, 410015
Research Site
Changsha, 430033
Research Site
Changzhou, 272100
Research Site
Chengdu, 610041
Research Site
Chongqing, 400010
Research Site
Chongqing, 400014
Research Site
Chongqing, 400042
Research Site
Deyang, 618000
Research Site
Guangzhou, 510100
Research Site
Ha’erbin, 150001
Research Site
Hangzhou, 310014
Research Site
Hefei, 230601
Research Site
Heze, 274099
Research Site
Jiujiang, 332000
Research Site
Luoyang, 471000
Research Site
Meihekou, 135022
Research Site
Nanchang, 330009
Research Site
Nanchong, 637900
Research Site
Nanjing, 210009
Research Site
Panjin, 124009
Research Site
Sanya, 572000
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
Research Site
Shenyang, 110004
Research Site
Shenyang, 110016
Research Site
Taiyuan, 030024
Research Site
Tianjin, 300457
Research Site
Tianjin
Research Site
Wuhan, 430010
Research Site
Wuhan, 430022
Research Site
Wuhan, 430060
Research Site
Xianyang, 712000
Research Site
Xianyang, 750004
Research Site
Xuzhou, 221000
Research Site
Yangzhou, 225001
Research Site
Yinchuan, 750001
Research Site
Zigong, 643021
Japan12 sites
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 260-0804
Research Site
Hamamatsu, 430-0929
Research Site
Kagoshima, 890-8520
Research Site
Koga-shi, 306-0232
Research Site
Meguro-ku, 153-0051
Research Site
Minatoku, 108-0073
Research Site
Minokamo Shi, 505-8510
Research Site
Osaka, 530-8480
Research Site
Toshima-ku, 171-0014
Research Site
Tsukuba, 305-0861
Research Site
Yokohama, 236-0004
Turkey (Türkiye)8 sites
Research Site
Ankara, 06800
Research Site
Ankara, 5000
Research Site
Cordaleo, 35575
Research Site
Edirne, 22030
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Research Site
Mersin, 33343
Russia7 sites
Research Site
Ivanovo, 153012
Research Site
Moscow, 111539
Research Site
Moscow, 119991
Research Site
Moscow, 121552
Research Site
Moscow, 129327
Research Site
Saint Petersburg, 195067
Research Site
Saint Petersburg, 197341
Argentina5 sites
Research Site
Bahía Blanca, 8000
Research Site
CABA, C1426
Research Site
Ciudad de Buenos Aires, C1419AHL
Research Site
San Miguel de Tucumán, T4000ICL
Research Site
San Nicolás de los Arroyos, B2900DPA
Vietnam5 sites
Research Site
Can Tho, 900000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh, 70000
Research Site
Hochiminh City, 700000
Australia4 sites
Research Site
Coffs Harbour, 02450
Research Site
Gosford, 2250
Research Site
Hoppers Crossing, 3029
Research Site
Ipswich, 4305
South Korea4 sites
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 04763
Research Site
Seoul, 05505
Philippines2 sites
Research Site
Iloilo City, 5000
Research Site
Quezon City, 1112
About this study
Official title: 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
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.
Read the detailed 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).
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Being tested
- Baxdrostat, Placebo
- Keywords
- Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaxdrostatDrug
Also called CIN-107
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
PlaceboDrug
Placebo tablet administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| 2 mg baxdrostat | Experimental | 2 mg baxdrostat administered orally, once daily (QD) Receives: Drug: Baxdrostat |
| 1 mg baxdrostat | Experimental | 1 mg baxdrostat administered orally, once daily (QD). Receives: Drug: Baxdrostat |
| placebo | Placebo comparator | Placebo administered orally, once daily (QD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Week 12
Secondary outcomes (10)
Change from baseline in seated SBP at Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12
Measured: At Week 12
Change from RWD baseline (Week 24) in seated SBP at Week 32
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal
Measured: At Week 32
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Measured: At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Measured: At Week 12
Change from baseline in seated DBP at Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated DBP at Week 12
Measured: At Week 12
Achieving seated SBP < 140 mmHg at Week 12
To assess the effect of 2 mg baxdrostat versus placebo on achieving seated SBP < 140 mmHg at Week 12
Measured: At Week 12
Change from baseline in seated DBP at Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12
Measured: At Week 12
Achieving seated SBP < 140 mmHg at Week 12
To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP < 140 mmHg at Week 12
Measured: At Week 12
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 in the rHTN subgroup
Measured: At Week 12
Change from baseline in seated SBP at Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start8 Apr 2024
- Primary completion24 Nov 2025
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344104
- Sponsor's protocol ID
- D6970C00008
- Acronym
- BaxAsia
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Flack JM, Azizi M, Brown JM, Dwyer JP, Jones ESW, Lihn AS, Liu L, Olsson DS, Perl S, Shibata H, Wang JG, Wilderang U, Wittes JT, Williams B. Baxdrostat for uncontrolled and resistant hypertension: rationale and design of the Phase 3 clinical trials BaxHTN, BaxAsia, and Bax24. Hypertens Res. 2025 Nov;48(11):2911-2923. doi: 10.1038/s41440-025-02297-7. Epub 2025 Aug 25.
PubMed 40850955
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06344104
- Acronym / sponsor ID
- BaxAsia / D6970C00008
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Keywords
- Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- placebo control
| Arm | Type | Receives |
|---|---|---|
| 2 mg baxdrostat | Experimental | Drug: Baxdrostat2 mg baxdrostat administered orally, once daily (QD) |
| 1 mg baxdrostat | Experimental | Drug: Baxdrostat1 mg baxdrostat administered orally, once daily (QD). |
| placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally, once daily (QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaxdrostatAlso: CIN-107Baxdrostat 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 | Drug | 1 mg baxdrostat, 2 mg baxdrostat |
| PlaceboPlacebo tablet administered orally, once daily (QD). | Drug | placebo |
Primary outcome
Change from baseline in seated SBP at Week 12
Time frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12
10 secondary outcomes
Change from baseline in seated SBP at Week 12
Time frame: At Week 12
Change from RWD baseline (Week 24) in seated SBP at Week 32
Time frame: At Week 32
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Time frame: At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Time frame: At Week 12
Change from baseline in seated DBP at Week 12
Time frame: At Week 12
Achieving seated SBP < 140 mmHg at Week 12
Time frame: At Week 12
Change from baseline in seated DBP at Week 12
Time frame: At Week 12
Achieving seated SBP < 140 mmHg at Week 12
Time frame: At Week 12
Change from baseline in seated SBP at Week 12
Time frame: At Week 12
Change from baseline in seated SBP at Week 12
Time frame: At Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 40850955Flack JM, Azizi M, Brown JM, Dwyer JP, Jones ESW, Lihn AS, Liu L, Olsson DS, Perl S, Shibata H, Wang JG, Wilderang U, Wittes JT, Williams B. Baxdrostat for uncontrolled and resistant hypertension: rationale and design of the Phase 3 clinical trials BaxHTN, BaxAsia, and Bax24. Hypertens Res. 2025 Nov;48(11):2911-2923. doi: 10.1038/s41440-025-02297-7. Epub 2025 Aug 25.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
93 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baxdrostat in people with Uncontrolled Hypertension and Resistant Hypertension, run by AstraZeneca at 93 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in China, Japan, Turkey (Türkiye), Russia, Argentina and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in seated SBP at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06344104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.