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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 (BaxAsia)

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

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi

+81-6-4802-3533

RD-clinical-information-Japan@astrazenec

Not Recruiting

April. 18, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male or female participants must be >= 18 years old

2. Mean seated SBP on automated office blood pressure measurement(AOBPM) >= 140 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 must 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 must 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 seated SBP on AOBPM >= 135 mmHg at Baseline

1. Mean seated SBP on AOBPM >= 170 mmHg at randomization

2. Mean seated SBP 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

Both

Uncontrolled Hypertension, Resistant Hypertension

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).

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

+81-3-6262-2811

Feb. 08, 2024

No

China/Hong Kong/India/Philippines/Republic of Korea/Russia/Turkey/Vietnam/Argentina