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 |
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| 相 | 第3相 |
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| スポンサー | AstraZeneca |
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| ステータス | 完了 |
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| 参加者数 | 796 名 |
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| 介入(薬剤) | Baxdrostat |
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| 開始日 | 2023年11月22日 |
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| 完了日 | 2025年5月21日 |
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| 結果公開日 | 2026年7月30日 |
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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 |
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| Double-Blind Treatment Period Weeks 0-12 Placebo | -5.8 ± 1.0 mmHg |
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| 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 |
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| Double-Blind Treatment Period Weeks 0-12 Placebo | -5.8 ± 1.0 mmHg |
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| p-value | <0.0001 |
| Least Square Mean Difference | -8.7 (95% CI -11.5–-5.8) |
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