HypertensionRandomised controlled trial

Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension

N Engl J MedPublished

  • Randomised controlled trial
  • phase 3
  • multinational
  • double-blind
  • placebo-controlled

Authors' conclusion

Among patients with uncontrolled or resistant hypertension, the addition of baxdrostat to background therapy resulted in a significantly lower seated systolic blood pressure at 12 weeks than placebo.

Study context

Population
Uncontrolled (2 drugs) or resistant (≥3 drugs, incl. a diuretic) hypertension, seated SBP 140 to <170 mm Hg794 received treatment
Participants
796 participants
Comparison
Baxdrostat 1 mg or 2 mg vs placebo, added to background therapy
  • 1-mg baxdrostatn = 264
  • 2-mg baxdrostatn = 266
  • Placebon = 264reference
Primary endpoint
Change in seated SBP from baseline
Follow-up
Week 12

Primary result

As reported in the abstract

Change in seated SBP (least-squares mean) · 12 weeks

1-mg baxdrostat

−14.5

least-squares mean change · 95% CI −16.5–-12.5 · mm Hg

2-mg baxdrostat

−15.7

least-squares mean change · 95% CI −17.6–-13.7 · mm Hg

Placebo

−5.8

least-squares mean change · 95% CI −7.9–-3.8 · mm Hg

Each group vs placeboPlacebo-corrected difference, mm Hg (95% CI)P value
1-mg baxdrostat
−8.7(−11.5 to −5.8)
P < 0.001
2-mg baxdrostat
−9.8(−12.6 to −7.0)
P < 0.001

Safety

Potassium >6.0 mmol/L

Original publication

Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. N Engl J Med. Published 30 August 2025. doi:10.1056/nejmoa2507109

Summarised from the published abstract; every number is checked against it