A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Baxdrostat
- Conditions
- Uncontrolled Hypertension
- Sponsor
- AstraZeneca
- Enrollment
- 796
- Locations
- 1
- Primary Endpoint
- Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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).
Investigators
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:
- •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
- •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
Arms & Interventions
2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
Intervention: Baxdrostat
1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD).
Intervention: Baxdrostat
Placebo
Placebo administered orally, once daily (QD).
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
Time Frame: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
Time Frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Secondary Outcomes
- Change from baseline in seated SBP for 2 mg baxdrostat(At Week 12)
- Achieving seated SBP < 130 mmHg for 2 mg baxdrostat(At Week 12)
- Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat(At Week 12)
- Change from baseline in seated DBP for 1 mg baxdrostat(At Week 12)
- Change from baseline in seated SBP for 1 mg baxdrostat(At Week 12)
- Achieving seated SBP < 130 mmHg for 1 mg baxdrostat(At Week 12)
- Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat(At Week 32)