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Corticosteroid

Baxdrostat for High Blood Pressure

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with mean seated systolic blood pressure (SBP) on automated office blood pressure measurement (AOBPM) >=130 mmHg and <170 mmHg at screening
Participants must have an estimated glomerular filtration rate (eGFR) >=45 mL/min/1.73 m^2 at screening
Must not have
Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening
Uncontrolled diabetes with glycated haemoglobin (HbA1c) >10.0% (86 mmol/mol) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8

Summary

"This trial is looking at how the cortisol levels in the blood change in people with high blood pressure before and after a specific test called ACTH stimulation."

Who is the study for?
This trial is for adults with uncontrolled high blood pressure, specifically those with a systolic blood pressure between 130 and 170 mmHg despite taking at least one antihypertensive medication including a diuretic. Participants must have stable blood pressure treatment for four weeks prior to the study, normal potassium levels, and adequate kidney function.
What is being tested?
The study is testing Baxdrostat's effect on cortisol levels after an ACTH stimulation test in comparison to a placebo. The focus is on changes from the start of the trial to Week 8 in people with uncontrolled hypertension.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like Baxdrostat may include electrolyte imbalances, low blood pressure episodes, dizziness or fatigue due to changes in hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My average blood pressure is between 130 and 170 mmHg.
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My kidney function test shows an eGFR of 45 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for or had heart artery surgery within the last 6 months.
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My diabetes is not under control, with an HbA1c level over 10.0%.
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I have the most severe heart failure symptoms, even at rest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Individual Cortisol Level
Secondary study objectives
Number of Participants with Abnormal Stimulated Cortisol

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Baxdrostat 2 mgExperimental Treatment1 Intervention
Participants will receive baxdrostat 2 mg tablet orally once daily.
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
Participants will receive placebo tablet orally once daily.
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
4,388 Previous Clinical Trials
289,109,857 Total Patients Enrolled
~0 spots leftby Nov 2024
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