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Study on Baxdrostat for Lowering Blood Pressure in Patients with Resistant Hypertension

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying resistant hypertension, a condition where blood pressure remains high despite using at least three different types of blood pressure medications, including a diuretic. The study will test a new treatment called Baxdrostat, which is a synthetic small molecule taken as a tablet. Participants in the study will either receive Baxdrostat or a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to determine if Baxdrostat can effectively reduce blood pressure in people with resistant hypertension. Participants will be randomly assigned to receive either Baxdrostat or the placebo. The study will last for several weeks, during which participants will take the assigned tablets and have their blood pressure monitored regularly. The main focus will be on changes in blood pressure over a 24-hour period at the end of the study.

Throughout the study, participants will continue their usual blood pressure medications alongside the trial treatment. The goal is to see if Baxdrostat can help lower blood pressure more effectively than the placebo. This research aims to provide new insights into managing resistant hypertension and improving treatment options for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant is required to meet specific criteria, including being 18 years or older and having a stable regimen of at least three different blood pressure medications, one of which must be a diuretic.
The participant's blood pressure must be within a certain range, and other health parameters such as kidney function and potassium levels are assessed.
Step 2
Randomization
Participants are randomly assigned to receive either baxdrostat or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
The dosage for baxdrostat is 2 mg, taken orally in tablet form.
Step 3
Treatment period
The treatment period lasts for 12 weeks. During this time, participants continue their assigned treatment and maintain their existing blood pressure medication regimen.
Participants are monitored for changes in their 24-hour average systolic blood pressure (SBP) and other related measurements.
Step 4
Monitoring and assessments
Throughout the study, participants undergo regular assessments to monitor blood pressure changes, both during the day and at night.
The primary goal is to observe any changes in the 24-hour average SBP by the end of the 12-week period.
Step 5
Completion of the study
At the end of the 12 weeks, participants complete the study. Final assessments are conducted to evaluate the effects of the treatment on blood pressure.
The study aims to determine if baxdrostat effectively reduces blood pressure and is safe for individuals with resistant hypertension.

Who can join the trial?

6 criteria

The participant must be at least 18 years old when they sign the consent form.
The average **systolic blood pressure (SBP)**, which is the top number in a blood pressure reading, should be 140 mmHg or higher but less than 170 mmHg when measured while seated during the screening.
The participant should be taking at least three different **blood pressure medications** from different classes, including at least one **diuretic** (a medication that helps the body get rid of extra salt and water), at the highest dose they can handle, for at least four weeks before the screening. If they don't meet this requirement, they might be allowed to try again at the doctor's discretion. **Beta blockers** used for other conditions like migraines or heart issues should not be counted as blood pressure medications for this study.
The participant should have an **estimated glomerular filtration rate (eGFR)** of 45 mL/min/1.73 m² or higher during the screening. This is a test that checks how well the kidneys are working.
The level of **potassium** in the blood should be 3.5 mmol/L or higher but less than 5.0 mmol/L during the screening. Potassium is a mineral that helps with nerve and muscle function.
For randomization, which is the process of assigning participants to different groups in the study, the average **ambulatory systolic blood pressure** should be 130 mmHg or higher. This is the blood pressure measured over 24 hours while the participant goes about their daily activities.

Who cannot join the trial?

1 criterion

Patients who have a type of high blood pressure called resistant hypertension, which means their blood pressure stays high even when taking at least three different blood pressure medications, including one that helps the body get rid of extra salt and water (a diuretic).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Bad Oeynhausen, Germany
Responsive
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

Baxdrostat is a medication being studied for its potential to lower blood pressure in people with resistant hypertension. Resistant hypertension is a condition where blood pressure remains high despite treatment with multiple blood pressure medications. The trial aims to see how well Baxdrostat can reduce the average systolic blood pressure over a 24-hour period after 12 weeks of treatment.

Baxdrostat

What is already known about the treatment

Baxdrostat – Baxdrostat is administered orally in tablet form. It is currently being studied in clinical trials for its potential to treat resistant hypertension, a condition where blood pressure remains high despite the use of multiple medications. The drug works by inhibiting an enzyme involved in the production of aldosterone, a hormone that increases blood pressure. Baxdrostat is classified as an antihypertensive agent, specifically targeting the renin-angiotensin-aldosterone system to help lower blood pressure.

Investigated diseases

Resistant Hypertension – Resistant hypertension is a condition where blood pressure remains above the desired level despite the use of at least three different types of blood pressure-lowering medications, including a diuretic, at their maximum tolerated doses. This condition is characterized by the body's inability to respond adequately to standard treatments, leading to persistently high blood pressure. Over time, the continued elevation of blood pressure can lead to increased stress on the heart and blood vessels. The condition may require additional medical interventions to manage effectively. It is important to monitor blood pressure regularly to assess the effectiveness of any treatment adjustments.