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 (BaxHTN)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Resistant Hypertension; Uncontrolled Hypertension

Treatments: Drug: Placebo; Drug: Baxdrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06034743

2023-505499-32-00 (Registry Identifier)

D6970C00002

Details and patient eligibility

About

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).

Enrollment: 796 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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796 participants in 3 patient groups, including a placebo group

2 mg baxdrostat

Experimental group

Description:

2 mg baxdrostat administered orally, once daily (QD).

Treatment:

Drug: Baxdrostat

1 mg baxdrostat

Experimental group

Description:

1 mg baxdrostat administered orally, once daily (QD).

Treatment:

Drug: Baxdrostat

Placebo

Placebo Comparator group

Description:

Placebo administered orally, once daily (QD).

Treatment:

Drug: Placebo