A Phase IIIb Study to Investigate the Effect of Baxdrostat in Chinese Participants With Uncontrol… (NCT07686120) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase IIIb Study to Investigate the Effect of Baxdrostat in Chinese Participants With Uncontrolled Hypertension.
286 participantsStarted 2026-09-30
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Serum potassium (K+) level ≥3.5 and \<5.0 mmol/L at screening, determined as per central laboratory.
. Only female participants:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in ambulatory 24-hour average Systolic blood pressure(SBP) at Week 12
. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
.1.1 Randomisation Criteria
. Ambulatory 24-hour average SBP ≥130 mmHg.
Exclusion criteria
. 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.
. 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.