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

Completed · Phase 3 · Has a placebo group

Conditions studied: Uncontrolled Hypertension, Resistant Hypertension

In brief

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Key facts

Study ID

NCT06034743

Run by

AstraZeneca

People needed

796

Starts

2023-11-22

Expected to finish

2025-10-10

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants must be ≥ 18 years old
• Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening
• Fulfil at least 1 of the following 2 criteria:
• uHTN subpopulation: have a stable regimen 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
• rHTN subpopulation: have a stable regimen 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
• Randomisation Criterion:
• Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit

You may not qualify if…

• Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
• Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
• Serum sodium level < 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
• New York Heart Association functional heart failure class IV at Screening
• Persistent atrial fibrillation

Where it is running

• Research Site — Gothenburg, Sweden
• Research Site — Uppsala, Sweden
• Research Site — Kaohsiung City, Taiwan
• Research Site — Kaohsiung City, Taiwan
• Research Site — Taichung, Taiwan
• Research Site — Taichung, Taiwan
• Research Site — Taichung, Taiwan
• Research Site — Taipei, Taiwan
• Research Site — Taipei, Taiwan
• Research Site — Taipei, Taiwan
• Research Site — Yung Kang City, Taiwan
• Research Site — Bangkok, Thailand
• Research Site — Bangkok, Thailand
• Research Site — Bangkok, Thailand
• Research Site — Chiang Mai, Thailand
• Research Site — Hat Yai, Thailand
• Research Site — Khon Kaen, Thailand
• Research Site — Pathum Thani, Thailand
• Research Site — Adana, Turkey (Türkiye)
• Research Site — Ankara, Turkey (Türkiye)
• Research Site — Bursa, Turkey (Türkiye)
• Research Site — Dinar, Turkey (Türkiye)
• Research Site — Istanbul, Turkey (Türkiye)
• Research Site — Izmir, Turkey (Türkiye)
• Research Site — Terrassa (Barcelona), Spain

Full record on ClinicalTrials.gov

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