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Baxdrostat for High Blood Pressure (Bax24 Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation
Participant must be ≥ 18 years old, at the time of signing the informed consent
Must not have
Persistent atrial fibrillation
New York Heart Association functional HF class IV at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12
Awards & highlights
Pivotal Trial

Summary

"This trial will test the safety and effectiveness of a new medication, Baxdrostat, in reducing high blood pressure in 212 participants with resistant hypertension. The participants will be randomly assigned to either receive

Who is the study for?
This trial is for adults with resistant hypertension, meaning their blood pressure remains high despite taking at least three different blood pressure medications, including a diuretic. They must have specific levels of kidney function and potassium in their blood to join.
What is being tested?
The study tests Baxdrostat's ability to lower systolic blood pressure compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo once daily, and their 24-hour ambulatory blood pressure will be monitored.
What are the potential side effects?
While the side effects are not detailed here, common ones associated with new antihypertensive drugs may include dizziness, headache, fatigue, low blood pressure (hypotension), and possible electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My average walking blood pressure is 130 mmHg or higher.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have ongoing irregular heartbeats.
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My heart failure is severe, limiting my ability to carry out physical activities.
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I have a known condition causing high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in ambulatory 24-hour average SBP
Secondary study objectives
Achieving a nocturnal SBP dipping of ≥ 10%
Change from baseline in ambulatory 24-hour average DBP
Change from baseline in ambulatory daytime average SBP
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2 mg baxdrostatExperimental Treatment1 Intervention
2 mg baxdrostat administered orally, once daily (QD).
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered orally, once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baxdrostat
2024
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,491 Total Patients Enrolled
~106 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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