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原発性アルドステロン症患者におけるバクスドロスタットの有効性と安全性を評価する研究
基本情報
- NCT ID
- NCT07007793
- ステータス
- 募集中
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 180
- 治験依頼者名
- AstraZeneca
概要
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.
対象疾患
原発性アルドステロン症
介入
Baxdrostat(DRUG)
Placebo(DRUG)
依頼者(Sponsor)
アストラゼネカ株式会社(INDUSTRY)