CTIS2023-505499-32-00
Recruiting
Phase 1
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 - BaxHT
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astrazeneca AB
- Enrollment
- 720
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
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: 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., 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.
Outcomes
Primary Outcomes
Not specified
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