Uncontrolled hypertension (uTHN) defined as blood pressure that remains higher than goal levels despite patients being treated with 2 anti-hypertensive agents, including a diuretic. Resistant hypertension (rHTN) defined as blood pressure that remains higher than goal levels despite the use of at least 3 anti hypertensive drugs of different classes at maximum tolerated dose, including a diuretic.
Conditions
Brief summary
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat., Change from baseline in seated systolic blood pressure for 1 mg baxdrostat., Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments.
Detailed description
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat., Change from baseline in seated SBP for 2 mg baxdrostat., Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat., Achieving seated SBP < 130 mmHg for 2 mg baxdrostat., Change from baseline in seated SBP for 1 mg baxdrostat., Change from baseline in seated DBP for 1 mg baxdrostat., Achieving seated SBP < 130 mmHg for 1 mg baxdrostat.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in seated systolic blood pressure for 2 mg baxdrostat., Change from baseline in seated systolic blood pressure for 1 mg baxdrostat., Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat., Change from baseline in seated SBP for 2 mg baxdrostat., Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat., Achieving seated SBP < 130 mmHg for 2 mg baxdrostat., Change from baseline in seated SBP for 1 mg baxdrostat., Change from baseline in seated DBP for 1 mg baxdrostat., Achieving seated SBP < 130 mmHg for 1 mg baxdrostat. | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Sweden