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A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
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).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
Find a site
Closest Location:
Research Site
Research sites nearby
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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
| DRUG: Baxdrostat
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
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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