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
- Conditions
- Uncontrolled HypertensionResistant Hypertension
- Interventions
- Drug: Placebo
- Registration Number
- NCT06344104
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
- Detailed Description
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 QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
-
Male or female participants must be ≥ 18 years old.
-
Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
-
Fulfil at least 1 of the following 2 criteria:
- uHTN subpopulation: have a stable regimen (≥ 4 weeks) 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 (≥ 4 weeks) 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.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 105 mmHg.
- Serum sodium level (Na+) < 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.
- NYHA functional heart failure class IV at Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 mg baxdrostat Baxdrostat 2 mg baxdrostat administered orally, once daily (QD) placebo Placebo Placebo administered orally, once daily (QD) 1 mg baxdrostat Baxdrostat 1 mg baxdrostat administered orally, once daily (QD).
- Primary Outcome Measures
Name Time Method Change from baseline in seated SBP at Week 12 At Week 12 To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in seated SBP at Week 12 At Week 12 To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup
Change from RWD baseline (Week 24) in seated SBP at Week 32 At Week 32 To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal
Achieving seated SBP < 140 mmHg at Week 12 At Week 12 To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP \< 140 mmHg at Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM At Week 12 To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Change from baseline in seated DBP at Week 12 At Week 12 To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12
Trial Locations
- Locations (1)
Research Site
🇻🇳Hochiminh, Vietnam