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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

NCT06034743

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Uncontrolled Hypertension, Resistant Hypertension

Interventions: Baxdrostat, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 must 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 must 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 the Baseline Visit

Exclusion Criteria:

* Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
* Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
* 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

Locations (263)

Saraland, Alabama, United States
Scottsdale, Arizona, United States
Sun City West, Arizona, United States
Surprise, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Lincoln, California, United States
Orange, California, United States
Rancho Cucamonga, California, United States
Stanford, California, United States
New Haven, Connecticut, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Springfield, Illinois, United States
Munster, Indiana, United States
Lexington, Kentucky, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Olive Branch, Mississippi, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Rosedale, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
New Bern, North Carolina, United States
Toledo, Ohio, United States
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