A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension

JRCT ID: jRCT2031230748

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uncontrolled Hypertension, Resistant Hypertension
• Date of first enrollment: 18/04/2024
• Target sample size: 30
• Countries of recruitment: China,Japan,Hong Kong,Japan,India,Japan,Philippines,Japan,Republic of Korea,Japan,Russia,Japan,Turkey,Japan,Vietnam,Japan,Argentina,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 administered orally, once daily (QD).

Outcome(s)

Primary Outcome

Change from baseline in siSBP at Week 12
- To assess the effect of 2 mgbaxdrostat versus placebo on siSBP at 12 weeks

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 siSBP on automated office blood pressure measurement(AOBPM) >= 140 mmHg and < 170 mmHg at Screening.

3. Fulfil at least 1 of the following 2 criteria: a) uHTN subpopulation: have a stable regimen (>= 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (atleast one should be a diuretic), at maximum tolerated dose in thejudgement of the Investigator b) rHTN subpopulation: have a stable regimen (>= 4 weeks) of >= 3 antihypertensive medications, from different therapeutic classes (atleast one should be a diuretic), at maximum tolerated dose in thejudgement 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. Mean siSBP on AOBPM >= 140 mmHg at Baseline

Exclude criteria

1. Mean siSBP on AOBPM >= 170 mmHg at randomization

2. Mean siDBP on AOBPM >= 105 mmHg at randomization

3. Serum sodiumlevel (Na+) < 135 mmol/L at Screening

4. Has the following known secondary causes of hypertension: renalartery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolledor untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation

5. NYHA functional heart failure class IV at Screening

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06344104