← Back to Search

Other

Baxdrostat for High Blood Pressure (BaxHTN 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
Male or female participants must be ≥ 18 years old
- uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
Must not have
New York Heart Association functional heart failure class IV at Screening
Persistent atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 54
Awards & highlights
Pivotal Trial

Summary

This trial tests Baxdrostat, a pill taken regularly, in adults with high blood pressure that isn't controlled by their current medications. Baxdrostat works by lowering the force of blood against artery walls.

Who is the study for?
This trial is for adults with high blood pressure not controlled by at least two medications, including a diuretic. Participants must have certain levels of potassium and kidney function. It's not for those with extremely high blood pressure or secondary causes like thyroid issues or specific heart conditions.
What is being tested?
The study tests Baxdrostat (1 or 2 mg daily) against a placebo in reducing systolic blood pressure. It's a Phase III trial where participants are randomly assigned to either the drug or placebo group without knowing which one they're receiving.
What are the potential side effects?
While the side effects aren't listed here, typical ones may include dizziness, headache, fatigue, and potential electrolyte imbalances due to its effect on blood pressure and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am on two different high blood pressure medications, including a diuretic, at the highest dose I can handle.
Select...
I take 3 or more blood pressure medicines, including a diuretic, at the highest dose I can tolerate.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 54 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 seated systolic blood pressure for 1 mg baxdrostat
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
Secondary study objectives
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
Change from baseline in seated DBP for 1 mg baxdrostat
+4 more
Other study objectives
Number of participants with adverse events (AEs)

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2 mg baxdrostatExperimental Treatment1 Intervention
2 mg baxdrostat administered orally, once daily (QD).
Group II: 1 mg baxdrostatExperimental Treatment1 Intervention
1 mg baxdrostat administered orally, once daily (QD).
Group III: 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include diuretics, which help the kidneys remove excess sodium and water, reducing blood volume; ACE inhibitors and ARBs, which relax blood vessels by inhibiting the renin-angiotensin-aldosterone system; beta-blockers, which reduce heart rate and the force of contraction; and calcium channel blockers, which relax blood vessel walls. Aldosterone antagonists, like spironolactone, block the effects of aldosterone, reducing sodium retention and blood pressure. Baxdrostat, an aldosterone synthase inhibitor, works by directly inhibiting the production of aldosterone, offering a targeted approach to reduce blood pressure. These mechanisms are crucial for managing high blood pressure, as they address different pathways that contribute to elevated blood pressure, providing comprehensive control and reducing the risk of cardiovascular events.
The mineralocorticoid receptor in skin disease.Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease.The role of the mineralocorticoid receptor in immune cells in cardiovascular disease.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,403 Previous Clinical Trials
289,124,289 Total Patients Enrolled
~327 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top