A clinical research study to learn if baxdrostat works at reducing ambulatory blood pressure and is safe for people with high blood pressure.
EU CTIS ID: 2023-507640-36-00
What this study is testing
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average systolic blood pressure (SBP) at Week 12.
- 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
- Participant must be ≥ 18 years old, at the time of signing the informed consent.
- Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
- 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, for at least 4 weeks prior to Screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
- Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
- Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
- Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.
You likely can't join if
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 110 mmHg
- Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
- Known secondary causes of hypertension.
- New York Heart Association functional HF class IV
- Persistent atrial fibrillation.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Vietnam
- United States
- Thailand
- Canada
- Malaysia
- Saudi Arabia
- Australia
- United Kingdom
- Argentina
- Philippines
- Taiwan
- Turkey
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 South Africa; Vietnam; United States; Thailand; Canada; Malaysia and 7 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.