Completed

NCT Number: 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

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).

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Key information

Conditions

Uncontrolled Hypertension Cardiovascular Diseases Hypertension Resistant Hypertension Vascular Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, CABA, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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
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

Treatment and study plan

baxdrostat

Drug

Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:

1 mg per tablet for 1 mg baxdrostat Arm;
2 mg per tablet for 2 mg baxdrostat Arm.

Other names: CIN-107

Placebo

Drug

Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Primary outcomes

Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12. All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12. All available measurements were included, and missing data were multiply imputed.

Secondary outcomes

Change From Randomised Withdrawal Baseline (Week 24) in Seated Systolic Blood Pressure (SBP) for 2 mg Baxdrostat

Time frame: At Week 32

To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal (RWD). All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated SBP for 2 mg Baxdrostat in the Resistant Hypertension Subpopulation

Time frame: At Week 12

To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation. All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 2 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12. All available measurements were included, and missing data were multiply imputed.
Number of Participants Who Achieved Seated SBP < 130 mmHg for 2 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12. All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated SBP for 1 mg Baxdrostat in the Resistant Hypertension Subpopulation

Time frame: At Week 12

To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation. All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 1 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 1 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12. All available measurements were included, and missing data were multiply imputed.
Number of Participants Who Achieved Seated SBP < 130 mmHg for 1 mg Baxdrostat

Time frame: At Week 12

To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12. All available measurements were included, and missing data were multiply imputed.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: BaxHTN

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Sep 13, 2023
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed