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

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).