Clinical trial NCT06034743: 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
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uncontrolled Hypertension
Resistant Hypertension
Keywords: Hypertension
Uncontrolled hypertension
Resistant hypertension
Blood pressure
Baxdrostat
CIN-107
Aldosterone
Aldosterone synthase
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).


Eligibility criteria: Inclusion Criteria:

* Male or female participants must be ≥ 18 years old
* Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
* Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen 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 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
* Randomisation Criterion:
* Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit

Exclusion Criteria:

* Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
* Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
* Serum sodium level \< 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
* New York Heart Association functional heart failure class IV at Screening
* Persistent atrial fibrillation

Primary outcomes:
measure: Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
timeFrame: At Week 12
measure: Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
timeFrame: At Week 12
Secondary outcomes:
measure: Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
timeFrame: At Week 32
measure: Change from baseline in seated SBP for 2 mg baxdrostat
timeFrame: At Week 12
measure: Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
timeFrame: At Week 12
measure: Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
timeFrame: At Week 12
measure: Change from baseline in seated SBP for 1 mg baxdrostat
timeFrame: At Week 12
measure: Change from baseline in seated DBP for 1 mg baxdrostat
timeFrame: At Week 12
measure: Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
timeFrame: At Week 12
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Week 54
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country: Vietnam
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References: