Bax24Baxdrostat's Effect on Resistant Hypertension Blood Pressure Reduction
This study aims to evaluate if the treatment with Baxdrostat can effectively reduce blood pressure in individuals with resistant hypertension, by comparing the change in 24-hour average systolic blood pressure from the beginning to the 12th week, against a placebo.
Baxdrostat
+ Placebo
Cardiovascular Diseases
+ Hypertension
+ Vascular Diseases
Treatment Study
Summary
Study start date: March 1, 2024
Actual date on which the first participant was enrolled.This study focuses on finding out if a medication called Baxdrostat can help lower blood pressure in people who have resistant hypertension. Resistant hypertension is a condition where blood pressure remains high despite the use of at least three different types of blood pressure-lowering medications. This research is important as it aims to provide a new option for those who struggle to control their blood pressure with current treatments, potentially reducing risks associated with high blood pressure such as heart attacks and strokes. Participants in this study will be randomly assigned to receive either Baxdrostat or a placebo—a substance with no active medication—once a day by mouth. The study is designed to be "double-blind," meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. The main focus will be on measuring changes in ambulatory systolic blood pressure, which is the top number in a blood pressure reading, as participants go about their daily activities. The study will also evaluate how safe and tolerable Baxdrostat is for those taking it. This approach helps to ensure the results are due to the medication itself and not other factors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.218 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 130 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 102 locations
Research Site
Hollywood, United StatesResearch Site
Lake Worth, United StatesResearch Site
Port Charlotte, United States