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A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

PHASE3RECRUITING

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

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Study details:

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Male or female participants must be ≥ 18 years old.

Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.

Fulfil at least 1 of the following 2 criteria: 1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator. 2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.

Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.

Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening.

Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Exclusion criteria

Mean seated SBP on AOBPM ≥ 170 mmHg.

Mean seated DBP on AOBPM ≥ 105 mmHg.

Serum sodium level (Na+) < 135 mmol/L at Screening.

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.

NYHA functional heart failure class IV at Screening.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-08

Primary completion: 2026-05-20

Study completion finish: 2026-05-20

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06344104

Intervention or treatment

DRUG: Baxdrostat

DRUG: Placebo

Conditions

• Uncontrolled Hypertension
• Resistant Hypertension

Image related to Uncontrolled Hypertension

Condition: Uncontrolled Hypertension, Resistant Hypertension
DRUG: Baxdrostat and other drugs
Coffs Harbour, Not Specified, Australia and more
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Coffs Harbour, Not Specified, Australia
Research Site
Gosford, Not Specified, Australia
Research Site
Hoppers Crossing, Not Specified, Australia
Research Site
Ipswich, Not Specified, Australia

Study Plan

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

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 2 mg baxdrostat 2 mg baxdrostat administered orally, once daily (QD)	DRUG: Baxdrostat Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: * 1 mg per tablet for 1mg baxdrostat Arm * 2 mg per tablet for 2mg baxdrostat Arm
EXPERIMENTAL: 1 mg baxdrostat 1 mg baxdrostat administered orally, once daily (QD).	DRUG: Baxdrostat Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: * 1 mg per tablet for 1mg baxdrostat Arm * 2 mg per tablet for 2mg baxdrostat Arm
PLACEBO_COMPARATOR: placebo Placebo administered orally, once daily (QD)	DRUG: Placebo Placebo tablet administered orally, once daily (QD).

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline in seated SBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12	At Week 12

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change from baseline in seated SBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12	At Week 12
Change from RWD baseline (Week 24) in seated SBP at Week 32	To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal	At Week 32
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM	To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM	To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12
Change from baseline in seated DBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on seated DBP at Week 12	At Week 12
Achieving seated SBP < 140 mmHg at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on achieving seated SBP \< 140 mmHg at Week 12	At Week 12
Change from baseline in seated DBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12	At Week 12
Achieving seated SBP < 140 mmHg at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP \< 140 mmHg at Week 12	At Week 12
Change from baseline in seated SBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup	At Week 12
Change from baseline in seated SBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup	At Week 12

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References

Clinical Trials Gov: A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension