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

第3相 完了 NCT06034743

対象疾患Uncontrolled Hypertension, Resistant Hypertension
第3相
スポンサーAstraZeneca
ステータス完了
参加者数796 名
介入(薬剤)Baxdrostat
開始日2023年11月22日
完了日2025年5月21日
結果公開日2026年7月30日

概要

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)

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