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

Phase 3Active Not RecruitingNCT06344104

AstraZeneca326 enrolled

Overview

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

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 QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

326

Conditions

Uncontrolled Hypertension Resistant Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female participants must be ≥ 18 years old. * Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening. * Fulfil at least 1 of the following 2 criteria: 1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) 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 (≥ 4 weeks) 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.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline. Exclusion Criteria: * Mean seated SBP on AOBPM ≥ 170 mmHg. * Mean seated DBP on AOBPM ≥ 105 mmHg. * Serum sodium level (Na+) \< 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. * NYHA functional heart failure class IV at Screening.

Locations (93)

Research Site

Bahía Blanca, Argentina

Research Site

CABA, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Nicolás de los Arroyos, Argentina

Research Site

Coffs Harbour, Australia

Outcomes

Primary Outcomes

Change from baseline in seated SBP at Week 12

To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12

Time frame: At Week 12

Secondary Outcomes

Change from baseline in seated SBP at Week 12

To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12

Time frame: At Week 12

Change from RWD baseline (Week 24) in seated SBP at Week 32

To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal

Time frame: At Week 32

Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM

To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12

Time frame: At Week 12

Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM

To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12

Time frame: At Week 12

Change from baseline in seated DBP at Week 12

To assess the effect of 2 mg baxdrostat versus placebo on seated DBP at Week 12

Time frame: At Week 12

Achieving seated SBP < 140 mmHg at Week 12

To assess the effect of 2 mg baxdrostat versus placebo on achieving seated SBP \< 140 mmHg at Week 12

Time frame: At Week 12

Change from baseline in seated DBP at Week 12

To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12

Time frame: At Week 12

Achieving seated SBP < 140 mmHg at Week 12

To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP \< 140 mmHg at Week 12

Time frame: At Week 12

Change from baseline in seated SBP at Week 12

To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup

Time frame: At Week 12

Change from baseline in seated SBP at Week 12

To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup

Time frame: At Week 12