BENITIONSClinical Trial Intelligence

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

3期 已完成 NCT06034743

适应症Uncontrolled Hypertension, Resistant Hypertension
分期3期
申办方AstraZeneca
状态已完成
受试者人数796 人
干预(药物)Baxdrostat
开始日期2023年11月22日
完成日期2025年5月21日
结果公布日2026年7月30日

摘要

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).

Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat

At Week 12 · mmHg

Double-Blind Treatment Period Weeks 0-12 Baxdrostat 2mg-15.7 ± 1.0 mmHg
Double-Blind Treatment Period Weeks 0-12 Placebo-5.8 ± 1.0 mmHg
p-value<0.0001
Least Square Mean Difference-9.8 (95% CI -12.6–-7.0)

Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat

At Week 12 · mmHg

Double-Blind Treatment Period Weeks 0-12 Baxdrostat 1mg-14.5 ± 1.0 mmHg
Double-Blind Treatment Period Weeks 0-12 Placebo-5.8 ± 1.0 mmHg
p-value<0.0001
Least Square Mean Difference-8.7 (95% CI -11.5–-5.8)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。