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Uncontrolled HypertensionPhase 3BaxNoDNCT07686120

A Phase IIIb Study to Investigate the Effect of Baxdrostat in Chinese Participants With Uncontrolled Hypertension.

A Phase 3 study testing baxdrostat 2mg in people with Uncontrolled Hypertension, run by AstraZeneca at 51 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase IIIb, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uncontrolled Hypertension
What is being tested?
baxdrostat 2mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
286 participants
Where
51 sitesChina
Study dates
17 Sep 2026to 9 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age 1. Participant must be ≥18 years old, at the time of signing the informed consent.
  • Type of Participant and Disease Characteristics
  • Mean seated SBP on AOBPM ≥140 mmHg and <170 mmHg at screening. Seated BP will be measured using standardised automated BP machines and using standardised procedures.
  • Have a stable regimen (≥ 4 weeks before the screening visit) of ≥ 2 antihypertensive medications, from different therapeutic classes (should not be a diuretic), at full doses per guidelines or maximum tolerated doses in the judgement of the Investigator, for at least 4 weeks prior to screening (participants who do not meet this criterion may be rescreened at the Investigator's discretion. Beta blockers used to treat other conditions (i.e., migraine, heart failure [HF], coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
  • Have eGFR ≥45 mL/min/1.73m2 at screening.
Show all 23Show fewer
  • Serum potassium (K+) level ≥3.5 and <5.0 mmol/L at screening, determined as per central laboratory.
  • Sex and Contraceptive/Barrier Requirements
  • Only female participants:
  • Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Female participants: i. Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
  • Women <50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels within the postmenopausal range.
  • Women ≥50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment ii. Female participants of child-bearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of child-bearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from 30 days before enrolment and throughout the study, and until at least 30 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician.
  • The following are not acceptable methods of contraception: periodic abstinence (calendar, symptom-thermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only and lactational amenorrhoea. Female condom and male condom should not be used together.
  • All females of child-bearing potential must have a negative pregnancy test result at screening and not be at stage of breastfeeding v. Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) ([periodic abstinence - e.g., calendar, ovulation, sympto-thermal, post-ovulation methods - declaration of abstinence for the duration of exposure to study intervention and withdrawal are not acceptable methods of contraception]); a vasectomised partner; subdermal contraceptive implants; bilateral tubal occlusion; intrauterine device/levonorgestrel intrauterine system; injectable contraceptive; oral contraceptive associated with inhibition of ovulation; and contraceptive transdermal patch, or vaginal ring.
  • Informed Consent
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • 5.1.1 Randomisation Criteria
  • Participants are eligible to be randomised to a treatment group only if all the following criteria apply:
  • Ambulatory 24-hour average SBP ≥130 mmHg.
  • Have an 80% to 120% adherence to placebo during the Run-in period, based on pill counts on the morning of randomization. Adherence will be derived for each patient based on pill counts as the number of pills taken (dispensed - returned), divided by the expected number of pills taken.
  • Have no change in background therapy regimen and dose consisting of ≥ 2 antihypertensive medications (none of which is a diuretic), for at least 4 weeks prior to randomisation. Beta-blockers used to treat other conditions (i.e., migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
  • Demonstrated good adherence to the prescribed antihypertensive medications by performing DOT.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions
  • As judged by the investigator, any evidence of which in the investigator's opinion makes it undesirable for the participant to participate in the study.
  • Mean seated SBP on AOBPM ≥170 mmHg (participants who do not meet this criterion may be rescreened at the Investigator's discretion, see Section 5.4.2 for rescreening criteria and Section 8.2.1 for BP measurement procedures).
  • Mean seated DBP on AOBPM ≥110 mmHg (participants who do not meet this criterion may be rescreened at the Investigator's discretion).
  • Serum sodium level (Na+) <135 mmol/L at screening, determined as per central laboratory.
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  • 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.
  • New York Heart Association functional HF class IV at Screening.
  • Medical history of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for HF within 6 months prior to Screening.
  • Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
  • Known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.
  • Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
  • Uncontrolled diabetes with HbA1c >10.0% (86 mmol/mol) at Screening.
  • Participants suspected to have severe cardiac hypertrophy.
  • Participants who are pregnant or breastfeeding. Prior/Concomitant Therapy
  • Simultaneous use of angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs) or angiotensin receptor-neprilysin inhibitor (ARNI) in current or prior treatment within the 4 weeks before screening
  • Prior medical treatment with any MRAs, antiarrhythmic medications (beta blockers and calcium channel blockers classified as Class II/IV antiarrhythmics used to treat hypertension, and digoxin are permitted), direct renin inhibitor, thiazide diuretic, loop diuretic, potassium-sparing diuretic, or other diuretics use within 4 weeks prior to screening.
  • Is expected to receive or is receiving any herbal anti-hypertensive medicine or antihypertensive medication of unknown ingredients.
  • Treatment with potassium binders within 1 month prior to screening.
  • Is expected to receive or is receiving any of the exclusionary drugs such as strong inducers of cytochrome P450 (CYP) 3A, chronic (taken more than 3 times a week for more than 3 months) use of NSAIDs (use of low-dose aspirin is permitted, as per medical judgement), and/or chronic use of systemic steroids within 8 weeks prior to screening.
  • Current or prior treatment within 6 months prior to screening with cytotoxic therapy.
  • Treatment with K+ supplements are not prohibited but should be continuously assessed and monitored throughout the trial.
  • Prior/Concurrent Clinical Study Experience
  • Known hypersensitivity to baxdrostat or drugs of the same class, or any of its excipients.
  • Participation in another clinical study with an IMP administered in the 3 months prior to randomisation in this study Other Exclusions
  • Participants working shifts (i.e., shifts that comprise working hours at different times on different days) or working night shifts.
  • Participants who cannot complete the 24-hour ABPM assessment at randomization (as judged by the Principal Investigator).

Trial locations and contacts

51 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

51 sites in 1 country

China51 sites, 51 recruiting

  • Research Site

    Beijing, 100029

    Recruiting

  • Research Site

    Beijing, 100034

    Not yet recruiting

  • Research Site

    Beijing, 100191

    Not yet recruiting

  • Research Site

    Beijing, 100730

    Not yet recruiting

  • Research Site

    Bengbu, 233004

    Not yet recruiting

  • Research Site

    Changchun, 130033

    Not yet recruiting

  • Research Site

    Changsha, 410005

    Not yet recruiting

  • Research Site

    Chengdu, 610031

    Not yet recruiting

  • Research Site

    Chengdu, 610078

    Not yet recruiting

  • Research Site

    Chongqing, 400038

    Not yet recruiting

  • Research Site

    Foshan, 528300

    Not yet recruiting

  • Research Site

    Fuzhou, 350005

    Not yet recruiting

  • Research Site

    Fuzhou, 350031

    Not yet recruiting

  • Research Site

    Guangzhou, 510100

    Not yet recruiting

  • Research Site

    Guangzhou, 510180

    Not yet recruiting

  • Research Site

    Guangzhou, 510515

    Not yet recruiting

  • Research Site

    Haikou, 570311

    Not yet recruiting

  • Research Site

    Hangzhou, 310006

    Not yet recruiting

  • Research Site

    Jinan, 250012

    Not yet recruiting

  • Research Site

    Jinan, 250021

    Not yet recruiting

  • Research Site

    Kunming, 650032

    Not yet recruiting

  • Research Site

    Lanzhou, 730030

    Not yet recruiting

  • Research Site

    Lu'an, 237005

    Not yet recruiting

  • Research Site

    Nanchang, 330006

    Not yet recruiting

  • Research Site

    Nanjing, 210029

    Not yet recruiting

  • Research Site

    Nanjing, 211103

    Not yet recruiting

  • Research Site

    Nanjing

    Not yet recruiting

  • Research Site

    Nanning, 530021

    Not yet recruiting

  • Research Site

    Ningbo, 315010

    Not yet recruiting

  • Research Site

    Qingdao, 266042

    Not yet recruiting

  • Research Site

    Shanghai, 200030

    Not yet recruiting

  • Research Site

    Shanghai, 200050

    Not yet recruiting

  • Research Site

    Shanghai, 200080

    Not yet recruiting

  • Research Site

    Shanghai, 200120

    Not yet recruiting

  • Research Site

    Shanghai, 310000

    Not yet recruiting

  • Research Site

    Shantou, 515041

    Not yet recruiting

  • Research Site

    Shenyang, 110016

    Not yet recruiting

  • Research Site

    Shenzhen, 518020

    Not yet recruiting

  • Research Site

    Shijiazhuang, 050051

    Not yet recruiting

  • Research Site

    Suzhou, 215002

    Not yet recruiting

  • Research Site

    Taiyuan, 030001

    Not yet recruiting

  • Research Site

    Taiyuan, 030032

    Not yet recruiting

  • Research Site

    Taizhou, 225300

    Not yet recruiting

  • Research Site

    Tianjin, 300121

    Not yet recruiting

  • Research Site

    Tianjin, 300457

    Not yet recruiting

  • Research Site

    Ürümqi, 830054

    Not yet recruiting

  • Research Site

    Wuhan, 430010

    Not yet recruiting

  • Research Site

    Wuhan, CN-430022

    Not yet recruiting

  • Research Site

    Xi'an, 710114

    Not yet recruiting

  • Research Site

    Yinchuan, 750004

    Not yet recruiting

  • Research Site

    Zhengzhou, 450003

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Baxdrostat on Ambulatory Blood Pressure in Chinese Participants With Uncontrolled Hypertension on Two or More Antihypertensive Medications Without Diuretics

This is a Phase IIIb, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN.

Consenting participants will be screened within 4 weeks and will subsequently enter a 4-week run-in period with placebo. Thereafter, participants will be randomised in a 1:1 ratio to receive one of the following 2 treatments QD, during a 12-week double-blind treatment period:

Read more

baxdrostat 2mg Placebo The randomisation will be stratified by mean ambulatory SBP at baseline (<140 mmHg, ≥140 mmHg) and the number of background antihypertensive medication classes (2, ≥3) at baseline.

During the 12-week double-blind treatment period, participants should remain on their background antihypertensive medication. Doses of background medications should not be changed during this period unless participants experience SBP < 100 mmHg with symptoms of hypotension. Rescue therapy is permitted if the SBP or DBP exceeds 170 or 105 mmHg, respectively. The choice of rescue therapy is based on the Investigator's best clinical judgement; however, the use of potassium-sparing diuretics and MRAs are prohibited.After completing the 12 weeks double-blind treatment period participants will complete a 2-week safety follow-up period. The total duration of study participation will be of approximately 22 weeks.

Read the detailed description

This is a Phase IIIb, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN, defined as BP targets not being achieved in an individual despite a stable regimen of ≥2 antihypertensive agents from different therapeutic classes (at full doses per guidelines or maximum tolerated dose in the judgement of the Investigator), none of which is a diuretic.

Consenting participants will be screened within 4 weeks and will subsequently enter a 4-week run-in period with placebo. Thereafter, participants will be randomised in a 1:1 ratio to receive one of the following 2 treatments QD, during a 12-week double-blind treatment period:

baxdrostat 2mg Placebo The randomisation will be stratified by mean ambulatory SBP at baseline (<140 mmHg, ≥140 mmHg) and the number of background antihypertensive medication classes (2, ≥3) at baseline.

During the 12-week double-blind treatment period, participants should remain on their background antihypertensive medication. Doses of background medications should not be changed during this period unless participants experience SBP < 100 mmHg with symptoms of hypotension. Rescue therapy is permitted if the SBP or DBP exceeds 170 or 105 mmHg, respectively. The choice of rescue therapy is based on the Investigator's best clinical judgement; however, the use of potassium-sparing diuretics and MRAs are prohibited.

After completing the 12 weeks double-blind treatment period participants will complete a 2-week safety follow-up period. The total duration of study participation will be of approximately 22 weeks.

The study is planned to be conducted in approximately 50 study sites across China.

A Data Monitoring Committee will be appointed for this study to monitor the safety and scientific integrity of a human research intervention and to make recommendations to AstraZeneca regarding the stopping of a study due to any harm.

An Executive Committee will be formed to provide scientific oversight and confirmation of the overall study design, of CSP and any protocol amendments (If appliable).

Being tested
baxdrostat 2mg, Placebo 2mg
Keywords
Uncontrolled Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • baxdrostat 2mgDrug

    baxdrostat 2mg tablet administered orally, once daily (QD).

  • Placebo 2mgDrug

    Placebo 2mg tablet administered orally, once daily (QD).

Study groups in NCT07686120
Study groupRoleWhat they receive
baxdrostat 2 mgExperimental2 mg baxdrostat administered orally, once daily (QD)
Receives: Drug: baxdrostat 2mg
Placebo 2mgPlacebo comparator2 mg placebo administered orally, once daily (QD)
Receives: Drug: Placebo 2mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in ambulatory 24-hour average Systolic blood pressure(SBP) at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory 24-hour average SBP at 12 weeks

    Measured: Week12

Secondary outcomes (13)

  1. Change from baseline in ambulatory night-time average Systolic blood pressure(SBP) at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory night-time average SBP at 12 weeks

    Measured: week12

  2. Change from baseline in ambulatory daytime average Systolic blood pressure(SBP) at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory daytime average Systolic blood pressure(SBP) at 12 weeks

    Measured: week12

  3. Change from baseline in seated Systolic blood pressure(SBP) at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on seated SBP at 12 weeks

    Measured: week12

  4. Percentage achieving ambulatory 24-hour average SBP <130 mmHg at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on achieving ambulatory 24-hour average SBP <130 mmHg at 12 weeks

    Measured: week12

  5. Change from baseline in ambulatory 24-hour Diastolic Blood Pressure(DBP) at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory 24-hour DBP at 12 week

    Measured: week12

  6. Change from baseline in ambulatory night-time average DBP at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory night-time average DBP at 12 weeks

    Measured: week12

  7. Change from baseline in ambulatory daytime average DBP at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on ambulatory daytime average DBP at 12 weeks

    Measured: week12

  8. Change from baseline in seated DBP at Week 12

    To assess the effect of baxdrostat 2mg versus placebo on seated DBP at 12 weeks

    Measured: week12

  9. Adverse Events (AE)s

    To assess the safety and tolerability of baxdrostat

    Measured: ICF to safety followup visit-approximately 22 weeks.

  10. Adverse Events of special interest (AESI)s -hyperkalaemia

    To assess the safety and tolerability of baxdrostat

    Measured: ICF to safety followup visit-approximately 22 weeks.

  11. Serious Adverse Event(SAE)s

    To assess the safety and tolerability of baxdrostat

    Measured: ICF to safety followup visit-approximately 22 weeks.

  12. Discontinuation of IP due to Adverse Event(DAE)s

    To assess the safety and tolerability of baxdrostat

    Measured: ICF to safety followup visit-approximately 22 weeks.

  13. Adverse Events of special interest (AESI)s- hyponatraemia

    To assess the safety and tolerability of baxdrostat

    Measured: ICF to safety followup visit-approximately 22 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start17 Sep 2026
  3. Primary completion9 Feb 2028 (estimated)
  4. Study completion9 Feb 2028 (estimated)

Resources

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
Consenting participants will be screened within 4 weeks and will subsequently enter a 4-week run-in period with placebo. Thereafter, participants will be randomised in a 1:1 ratio to receive one of the following 2 treatments QD, during a 12-week double-blind treatment period: baxdrostat 2mg Placebo The randomisation will be stratified by mean ambulatory SBP at baseline (\<140 mmHg, ≥140 mmHg) and the number of background antihypertensive medication classes (2, ≥3) at baseline.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686120
Sponsor's protocol ID
D6970L00002
Acronym
BaxNoD
Status last verified
Oct 2026
First submitted
22 May 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing baxdrostat 2mg in people with Uncontrolled Hypertension, run by AstraZeneca at 51 sites in China.

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 23 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in ambulatory 24-hour average Systolic blood pressure(SBP) at Week 12 (time frame: Week12). 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 NCT07686120.

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 15 Oct 2026.

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