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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505499-32-00
Acronym
BaxHTN / D6970C00002
Enrollment
205
Registered
2024-02-16
Start date
2024-03-08
Completion date
2025-10-07
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026