A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Baxdrostat
- Conditions
- Resistant Hypertension
- Sponsor
- AstraZeneca
- Enrollment
- 218
- Locations
- 102
- Primary Endpoint
- Change from baseline in ambulatory 24-hour average SBP
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
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 must be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to screening. 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.
- •Mean seated DBP on AOBPM ≥ 110 mmHg.
- •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.
- •Persistent atrial fibrillation.
Arms & Interventions
2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
Intervention: Baxdrostat
Placebo
Placebo administered orally, once daily (QD)
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in ambulatory 24-hour average SBP
Time Frame: At Week 12
To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average SBP at Week 12.
Secondary Outcomes
- Change from baseline in ambulatory night-time average SBP(At Week 12)
- Change from baseline in ambulatory daytime average SBP(At Week 12)
- Change from baseline in seated SBP(At Week 12)
- Participants achieving ambulatory 24-hour average SBP of < 130 mmHg(At Week 12)
- Change from baseline in ambulatory 24-hour average DBP(At Week 12)
- Change from baseline in ambulatory night-time average DBP(At Week 12)
- Change from baseline in the average ambulatory daytime average DBP(At Week 12)
- Change from baseline on seated DBP(At Week 12)
- Participants achieving a nocturnal SBP dipping of ≥ 10%(At Week 12)