This clinical trial is focused on studying the effects of a medication called Baxdrostat on people with high blood pressure, also known as hypertension. Specifically, it looks at two types of high blood pressure: uncontrolled hypertension, where blood pressure remains high despite treatment with two medications, and resistant hypertension, where blood pressure stays high even with three different medications. The study aims to see if Baxdrostat can help reduce blood pressure and if it is safe for use.
Participants in the study will receive either Baxdrostat or a placebo. Baxdrostat is taken in the form of a tablet. The study will compare the effects of two different doses of Baxdrostat, 1 mg and 2 mg, over a period of 12 weeks. The main goal is to observe changes in blood pressure levels while sitting, and to monitor any side effects or safety concerns that may arise during the study.
The study will help determine if Baxdrostat is effective in lowering blood pressure in people who have not achieved their target blood pressure levels with other medications. By participating in this study, researchers hope to gather important information about the potential benefits and safety of Baxdrostat for treating high blood pressure.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, blood pressure levels, and current medication regimen.
Participants must have a stable regimen of antihypertensive medications, including a diuretic, at maximum tolerated doses.
2baseline assessment
Initial assessments are conducted to establish baseline measurements, including seated systolic blood pressure.
Blood tests are performed to check kidney function and potassium levels.
3randomization
Participants are randomly assigned to receive either baxdrostat or a placebo.
The study is double-blind, meaning neither participants nor researchers know who receives the active medication.
4medication administration
Participants take baxdrostat or placebo orally in tablet form.
Dosages are either 1 mg or 2 mg, administered daily for a period of 12 weeks.
5follow-up assessments
Regular follow-up visits are scheduled to monitor blood pressure and assess any side effects.
Safety and tolerability are evaluated through clinical and laboratory assessments.
6end of treatment evaluation
At the end of the 12-week period, a final assessment of blood pressure is conducted.
The effectiveness of baxdrostat in reducing blood pressure is compared to the placebo.
7post-study follow-up
Participants may be monitored for any long-term effects or changes in health status.
Additional assessments may be conducted to gather further data on the medication’s impact.
Who Can Join the Study?
Participants must be male or female and at least 18 years old.
The average sitting systolic blood pressure (the top number in a blood pressure reading) should be between 140 mmHg and 170 mmHg during the screening.
Participants must meet at least one of the following conditions:
For the uHTN subpopulation: Have a stable treatment plan with 2 different blood pressure medications, including a diuretic (a medication that helps remove excess fluid from the body), at the highest dose they can tolerate.
For the rHTN subpopulation: Have a stable treatment plan with 3 or more different blood pressure medications, including a diuretic, at the highest dose they can tolerate.
The estimated glomerular filtration rate (a measure of kidney function) should be at least 45 mL/min/1.73m² during the screening.
The level of serum potassium (a mineral in the blood) should be between 3.5 and 5.0 mmol/L during the screening.
At the start of the trial, the sitting systolic blood pressure should be at least 135 mmHg when measured in the office.
Who Cannot Join the Study?
Patients with uncontrolled hypertension, which means their blood pressure is still too high even though they are taking two different blood pressure medicines, including one that helps the body get rid of extra salt and water.
Patients with resistant hypertension, which means their blood pressure is still too high even though they are taking at least three different blood pressure medicines at the highest dose they can handle, including one that helps the body get rid of extra salt and water.
Baxdrostat is a medication being studied for its ability to lower blood pressure in people who have high blood pressure that is not well controlled, even when they are taking two or more other blood pressure medications. The trial is looking at how effective and safe Baxdrostat is in reducing systolic blood pressure, which is the top number in a blood pressure reading, over a period of 12 weeks.
Uncontrolled Hypertension – This condition occurs when blood pressure remains above the desired level despite treatment with two different types of blood pressure-lowering medications, including a diuretic. It is characterized by persistently high blood pressure readings that do not reach target levels. Over time, this can lead to increased strain on the heart and blood vessels. Patients may experience symptoms such as headaches, dizziness, or no symptoms at all. The condition requires careful monitoring and management to prevent complications.
Resistant Hypertension – This condition is defined by blood pressure that remains above target levels despite the use of at least three different classes of blood pressure medications at their maximum tolerated doses, including a diuretic. It indicates a more severe form of high blood pressure that is difficult to control. Patients with resistant hypertension may have an increased risk of cardiovascular problems. The condition often requires a comprehensive approach to management, including lifestyle changes and possibly additional medications.
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