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A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

PHASE3RECRUITING

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

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Study details:

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

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Eligibility criteria

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

Inclusion criteria

Participant must be ≥ 18 years old, at the time of signing the informed consent.

Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.

Have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to Screening (participants who do not meet this criterion may be rescreened at the Investigator's discretion). Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.

Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.

Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory

Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion criteria

Mean seated SBP on AOBPM ≥ 170 mmHg at Screening.

Mean seated DBP on AOBPM ≥ 110 mmHg at Screening.

Serum sodium level < 135 mmol/L at Screening, as per central laboratory.

Participant 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.

New York Heart Association functional HF class IV at Screening.

Persistent atrial fibrillation.

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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: 2024-03-01

Primary completion: 2025-09-05

Study completion finish: 2025-09-05

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06168409

Intervention or treatment

DRUG: Baxdrostat

DRUG: Placebo

Conditions

• Resistant Hypertension

Condition: Resistant Hypertension
DRUG: Baxdrostat and other drugs
Clayton, 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
Clayton, Not Specified, Australia
Research Site
Perth, 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: • 2 mg per tablet.
PLACEBO_COMPARATOR: Placebo Placebo administered orally, once daily (QD)	DRUG: Placebo Placebo tablet matching baxdrostat, 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 ambulatory 24-hour average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average SBP at Week 12.	At Week 12

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change from baseline in ambulatory night-time average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average SBP at Week 12.	At Week 12
Change from baseline in ambulatory daytime average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average SBP at Week 12.	At Week 12
Change from baseline in seated SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated SBP at Week 12.	At Week 12
Participants achieving ambulatory 24-hour average SBP of < 130 mmHg	To assess the effect of treatment with baxdrostat 2 mg versus placebo on achieving ambulatory 24-hour average SBP \< 130 mmHg at Week 12.	At Week 12
Change from baseline in ambulatory 24-hour average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average DBP at Week 12.	At Week 12
Change from baseline in ambulatory night-time average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average DBP at Week 12.	At Week 12
Change from baseline in the average ambulatory daytime average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average DBP at Week 12.	At Week 12
Change from baseline on seated DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated DBP at Week 12.	At Week 12
Achieving a nocturnal SBP dipping of ≥ 10%	To assess the effect of treatment with baxdrostat 2 mg versus placebo in the nocturnal dipping pattern at Week 12.	At Week 12.

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References

Clinical Trials Gov: A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension