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

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). - BaxHTN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230558

Enrollment

Registered

2024-01-11

Start date

2024-01-11

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Hypertension, Resistant Hypertension

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female participants must be >= 18 years old 2. Mean sitting systolic blood pressure on automated office blood pressure measurement >= 140 mmHg and = 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator 4. Estimated glomerular filtration rate >= 45 mL/min/1.73m2 at Screening 5. Serum potassium (K+) level >= 3.5 and = 135 mmHg at baseline

Exclusion criteria

Exclusion criteria: 1. Mean sitting systolic blood pressure on attended automated office blood pressure measurement >= 170 mmHg 2. Mean seated diastolic blood pressure on attended automated office blood pressure measurement >= 110 mmHg 3. Serum sodium level < 135 mmol/L at Screening 4. 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 5. New York Heart Association functional heart failure class IV at Screening 6. Persistent atrial fibrillation

Design outcomes

Primary

Measure	Time frame
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 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	—

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, UK, US, Vietnam

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026