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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
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
CompletedPhase 3
Sponsor: AstraZeneca
Conditions: Uncontrolled Hypertension, Resistant Hypertension
Interventions: Baxdrostat, Placebo
Countries: Argentina, Australia, China, Hong Kong, India, Japan, Philippines, Russia
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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.
Locations (93)
- Bahía Blanca, Argentina
- CABA, Argentina
- Ciudad de Buenos Aires, Argentina
- San Miguel de Tucumán, Argentina
- San Nicolás de los Arroyos, Argentina
- Coffs Harbour, Australia
- Gosford, Australia
- Hoppers Crossing, Australia
- Ipswich, Australia
- Baotou, China
- Beijing, China
- Beijing, China
- Bengbu, China
- Changde, China
- Changsha, China
- Changsha, China
- Changzhou, China
- Chengdu, China
- Chongqing, China
- Chongqing, China
- Chongqing, China
- Deyang, China
- Guangzhou, China
- Hangzhou, China
- Ha’erbin, China
- Hefei, China
- Heze, China
- Jiujiang, China
- Luoyang, China
- Meihekou, China
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