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 Hypertensio

Phase 3

• Conditions: ncontrolled Hypertension, Resistant Hypertension

• Registration Number: JPRN-jRCT2031230558
• Lead Sponsor: Ageishi Yuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Male or female participants must be >= 18 years old

2. Mean sitting systolic blood pressure on automated office blood pressure measurement >= 140 mmHg and < 170 mmHg at Screening

3. Fulfil at least 1 of the following 2 criteria:
a) 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
b) 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

4. Estimated glomerular filtration rate >= 45 mL/min/1.73m2 at Screening

5. Serum potassium (K+) level >= 3.5 and < 5.0 mmol/L at Screening

6. Sitting systolic blood pressure on attended automated office blood pressure measurement of >= 135 mmHg at baseline

Exclusion Criteria

1. Mean sitting systolic blood pressure on attended automated office blood pressure measurement >= 170 mmHg at Randomisation

2. Mean seated diastolic blood pressure on attended automated office blood pressure measurement >= 110 mmHg at Randomisation

3. Serum sodium level < 135 mmol/L at Screening

4. 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

5. New York Heart Association functional heart failure class IV at Screening

6. Persistent atrial fibrillation

Study & Design

• Study Type: Interventional
• Study Design: Not specified