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E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
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In the Phase 3 BaxHTN study in adults with uncontrolled (uHTN) or resistant (rHTN) hypertension, the selective aldosterone synthase inhibitor, baxdrostat, at 1 and 2 mg/day in addition to background therapy, lowered seated office systolic blood pressure (SBP) by 8.7 and 9.8 mmHg, respectively, vs placebo at 12 weeks. BaxAsia (NCT06344104) has a similar randomised, double-blind design comparing the efficacy and safety of baxdrostat vs placebo in hypertensive patients primarily from Asia. Here, we present the baseline characteristics of participants included in BaxAsia.
Adults aged ≥18 years were eligible if they had: uHTN or rHTN, defined as mean seated SBP between ≥140 and <170 mmHg despite stable treatment with 2 (uHTN) or ≥3 (rHTN) antihypertensive medications (including a diuretic) at maximally tolerated dose; an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2; and a serum potassium level between ≥3.5 and <5.0 mmol/L. After a 2-week placebo run-in period, participants with a mean seated SBP ≥135 mmHg were randomised 1:1:1 to baxdrostat 1 mg, baxdrostat 2 mg or placebo once daily for a 12-week double-blind period. This was followed by 3 sequential periods: 12-week open-label period (baxdrostat 2 mg); 8-week double-blind randomised withdrawal period (randomised 2:1 to baxdrostat 2 mg or placebo); 20-week open-label period (baxdrostat 2 mg). The primary endpoint is change in seated SBP from baseline to Week 12 with baxdrostat 2 mg vs placebo.
Overall, 666 participants were screened and 326 were randomised; 49.4% had uHTN and 50.6% had rHTN. Mean (standard deviation, SD) age and body mass index were 59.2 (11.5) years and 29.3 (5.3) kg/m2, respectively. Overall, 57.7% were male, 62.3% were Asian and 37.1% were White. Participants were recruited from China mainland (47.9%), Russia (20.6%), Turkey (9.5%), Japan (9.2%), Argentina (4.6%), Australia (3.1%), South Korea (2.1%), Vietnam (1.8%), China Hong Kong (0.9%) and India (0.3%).
At baseline, mean (SD) seated SBP was 149.0 (8.7) mmHg despite treatment with 2–5 antihypertensive medications. Participants with rHTN were on 3 (67.9%), 4 (26.1%) or 5 (6.1%) antihypertensive medications at baseline. Baseline eGFR, serum potassium and sodium levels were 88.2 (17.9) mL/min/1.73 m2, 4.2 (0.4) mmol/L and 140.7 (2.5) mmol/L, respectively. In total, 40.5% of participants had a history of dyslipidaemia, 36.8% obesity, 25.2% type 2 diabetes, 7.1% coronary artery stenosis, 7.4% chronic kidney disease, 4.6% myocardial infarction, 4.6% heart failure and 4.3% stroke. Overall, 99.4% of participants had primary hypertension and 0.6% had secondary hypertension (kidney disease). At baseline, all participants were on diuretic, 96.3% on ACEi, ARB or ARNI, 48.5% on calcium channel blocker, 16.0% on beta blocker and 8.3% on other medications.
Participants randomised in BaxAsia were representative of adults primarily from Asia with uHTN or rHTN with elevated SBP despite multiple antihypertensive medications. A history of dyslipidaemia, type 2 diabetes and/or obesity were the most common comorbidities. BaxAsia will assess the seated office blood pressure-lowering effect and safety of baxdrostat in the study participants.