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A study to learn if baxdrostat works at reducing blood pressure and is safe in people with high blood pressure
EU CTIS ID: 2023-505499-32-00
What this study is testing
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at week 12. To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at week 12. Safety: To assess the safety and tolerability of baxdrostat versus placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 must 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 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
- Randomisation Criterion: Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Turkey
- Japan
- United Kingdom
- United States
- Thailand
- Malaysia
- India
- South Africa
- Taiwan
- Korea, Republic of
- Vietnam
- Canada
- Israel
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Turkey; Japan; United Kingdom; United States; Thailand and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.