Last updated 58 days ago
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
300 patients around the world
Available in Argentina
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).
AstraZeneca
300Patients around the world
This study is for people with
Arterial hypertension
Uncontrolled arterial hypertension
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female participants must be ≥ 18 years old.Mean siSBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg and < 170 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 should 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 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.Mean siSBP on AOBPM ≥ 140 mmHg at Baseline.
- Mean siSBP on AOBPM ≥ 170 mmHg at randomisation.Mean siDBP on AOBPM ≥ 105 mmHg at randomization.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.
StudyBaxAsia
SponsorAstraZeneca
Conditions
Uncontrolled arterial hypertension
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06344104
