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NCT06344104

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

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2026-04-03

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Uncontrolled Hypertension Resistant Hypertension

Keywords

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Hypertension Uncontrolled hypertension Resistant hypertension Blood pressure Baxdrostat CIN-107 Aldosterone Aldosterone synthase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo control

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2 mg baxdrostat

2 mg baxdrostat administered orally, once daily (QD)

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

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

* 1 mg per tablet for 1mg baxdrostat Arm
* 2 mg per tablet for 2mg baxdrostat Arm

1 mg baxdrostat

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

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

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

* 1 mg per tablet for 1mg baxdrostat Arm
* 2 mg per tablet for 2mg baxdrostat Arm

placebo

Placebo administered orally, once daily (QD)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet administered orally, once daily (QD).

Interventions

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Baxdrostat

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

* 1 mg per tablet for 1mg baxdrostat Arm
* 2 mg per tablet for 2mg baxdrostat Arm

Intervention Type DRUG

Placebo

Placebo tablet administered orally, once daily (QD).

Intervention Type DRUG

Other Intervention Names

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CIN-107

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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Argentina Australia China Hong Kong India Japan Philippines Russia South Korea Turkey (Türkiye) Vietnam

Other Identifiers

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D6970C00008

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

2 mg baxdrostat

Baxdrostat

1 mg baxdrostat

Baxdrostat

placebo

Placebo

Interventions

Baxdrostat

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Locations

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