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A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Baxdrostat
  • drug: Placebo

Eligibility


Inclusion Criteria:

   - Male or female participants must be ≥ 18 years old

   - Mean sitting systolic blood pressure on automated office blood pressure measurement ≥
   140 mmHg and < 170 mmHg at Screening

   - Fulfil at least 1 of the following 2 criteria:

      1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from
      different therapeutic classes (at least one should be a diuretic), at maximum
      tolerated dose in the judgement of the Investigator

      2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications,
      from different therapeutic classes (at least one should be a diuretic), at
      maximum tolerated dose in the judgement of the Investigator

   - Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening

   - Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening

   - Randomisation Criterion:

   - Sitting systolic blood pressure on attended automated office blood pressure
   measurement of ≥ 135 mmHg at baseline

Exclusion Criteria:

   - Mean sitting systolic blood pressure on attended automated office blood pressure
   measurement ≥ 170 mmHg at Randomisation

   - Mean seated diastolic blood pressure on attended automated office blood pressure
   measurement ≥ 110 mmHg at Randomisation

   - Serum sodium level < 135 mmol/L at Screening

   - 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 heart failure class IV at Screening

   - Persistent atrial fibrillation

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting