What side effects are associated with this type of intervention?

Common treatments for high blood pressure include Aldosterone Receptor Antagonists (ARAs) like spironolactone and eplerenone, which can cause side effects such as hyperkalemia (elevated potassium levels), gynecomastia (breast enlargement in men), and renal dysfunction. Other common antihypertensive medications include ACE inhibitors, which may cause cough and angioedema; beta-blockers, which can lead to fatigue and bradycardia; and diuretics, which may result in electrolyte imbalances and dehydration. Baxdrostat, an Aldosterone Synthase Inhibitor, is being studied for its efficacy and safety, and its side effect profile may include similar risks associated with ARAs.

What prior FDA approvals exist?

The FDA has approved various classes of drugs for the treatment of high blood pressure, including ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics. Specifically related to aldosterone, aldosterone receptor antagonists such as spironolactone and eplerenone have been used to manage hypertension and heart failure by blocking the effects of aldosterone. Baxdrostat, an aldosterone synthase inhibitor, represents a novel approach by inhibiting the production of aldosterone, potentially offering a new therapeutic option for patients with resistant hypertension.

What other types of research exist?

Promising novel alternatives to Baxdrostat for high blood pressure treatment include: <ol> <li>SGLT2 inhibitors (e.g., Dapagliflozin) - These have shown benefits in reducing blood pressure and improving cardiovascular outcomes.</li> <li></li> </ol> Angiotensin receptor-neprilysin inhibitors (ARNIs) - These combine an ARB with a neprilysin inhibitor and have shown efficacy in reducing blood pressure and heart failure outcomes. 3. Endothelin receptor antagonists (e.g., Macitentan) - Although primarily used for pulmonary hypertension, they are being explored for systemic hypertension. 4. PDE-5 inhibitors (e.g., Sildenafil) - These have shown potential in improving hemodynamic parameters in heart failure patients, which may translate to blood pressure benefits.

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Baxdrostat for High Blood Pressure (BaxHTN Trial)

Q: What is the mechanism of action of this treatment?

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.

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

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I am 18 years old or older.

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I am on two different high blood pressure medications, including a diuretic, at the highest dose I can handle.

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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:

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My heart failure is severe, limiting my ability to carry out physical activity.

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I have ongoing irregular heartbeats.

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I have a known condition causing high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 54

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

0 / 6Eligibility criteria met

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.

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