Completed

Bax24Baxdrostat's Effect on Resistant Hypertension Blood Pressure Reduction

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

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.

What is being tested

Baxdrostat

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases

+ Hypertension

+ Vascular Diseases

From 18 to 130 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
NCT06168409
Principal SponsorAstraZeneca
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

218 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular DiseasesHypertensionVascular Diseases

Criteria

6 inclusion criteria required to participate
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.

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6 exclusion criteria prevent from participating
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.

Participant 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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
2 mg baxdrostat administered orally, once daily (QD).

Group II

Placebo
Placebo administered orally, once daily (QD)

Study 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

Suspended

Research Site

Surprise, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Hollywood, United States
Suspended

Research Site

Lake Worth, United States
Suspended

Research Site

Port Charlotte, United States
Completed102 Study Centers