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Investigating Baxdrostat for Uncontrolled Hypertension

A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

PHASE3 · AstraZeneca · NCT06344104

This study is testing if a new medication called baxdrostat can help people with high blood pressure that doesn't respond to regular treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Locations112 sites (Bahia Blanca and 111 other locations)
Trial IDNCT06344104 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of baxdrostat in participants suffering from uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The study involves a multicenter, randomized, double-blinded, placebo-controlled design, comparing the effects of 1 mg and 2 mg doses of baxdrostat against a placebo over a 12-week period. Approximately 300 participants aged 18 and older, who are on a stable regimen of antihypertensive medications, will be enrolled to assess changes in systolic blood pressure (SBP). The primary objective is to determine the difference in SBP reduction from baseline at Week 12 between the treatment and placebo groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with uncontrolled or resistant hypertension despite being on multiple antihypertensive medications.

Not a fit: Patients with severely elevated blood pressure or those not meeting the study's medication regimen criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with difficult-to-control hypertension.

How similar studies have performed: Previous studies have shown promise in treating hypertension with similar approaches, but the specific efficacy of baxdrostat is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bahia Blanca and 111 other locations

+62 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Uncontrolled Hypertension, Resistant Hypertension, Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.