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

JRCT ID: jRCT2031230558

Registered date:11/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uncontrolled Hypertension, Resistant Hypertension
• Date of first enrollment: 31/01/2024
• Target sample size: 75
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Denmark,Japan,France,Japan,Germany,Japan,India,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Netherlands,Japan,Poland,Japan,Slovakia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,UK,Japan,US,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 < 170 mmHg at Screening

3. Fulfil at least 1 of the following 2 criteria:
a) uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
b) rHTN subpopulation: have a stable regimen of >= 3 antihypertensive medications, from different therapeutic classes (at least one
should 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 < 5.0 mmol/L at Screening

6. Sitting systolic blood pressure on attended automated office blood pressure measurement of >= 135 mmHg at baseline

Exclude criteria

1. Mean sitting systolic blood pressure on attended automated office blood pressure measurement >= 170 mmHg at Randomisation

2. Mean seated diastolic blood pressure on attended automated office blood pressure measurement >= 110 mmHg at Randomisation

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

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06034743