A study to learn if baxdrostat works at reducing blood pressure and is safe in people with high blood pressure

Phase 1

Recruiting

• Conditions: ncontrolled hypertension (uTHN) defined as blood pressure that remains higher than goal levels despite patients being treated with 2 anti-hypertensive agents, including a diuretic.Resistant hypertension (rHTN) defined as blood pressure that remains higher than goal levels despite the use of at least 3 anti hypertensive drugs of different classes at maximum tolerated dose, including a diuretic.; MedDRA version: 21.1Level: LLTClassification code: 10081349Term: Resistant hypertension Class: 10047065; MedDRA version: 21.1Level: LLTClassification code: 10066860Term: Uncontrolled hypertension Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-505499-32-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 720

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified