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LCZ696単剤療法でコントロール不良なグレード1および2の高血圧患者におけるLCZ696/アムロジピンの有効性と安全性の試験
基本情報
- NCT ID
- NCT06236061
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 718
- 治験依頼者名
- Novartis
概要
This CLAZ696B11302 study is composed of two parts; the Core part including double-blind period, and the open-label extension (OLE) part which is an open-label extension of the Core part. The purpose of the Core part is to demonstrate that LCZ696 (LCZ) when used in combination with amlodipine (AML), denoted as LCZ/AML, will provide greater blood pressure lowering benefit compared to LCZ monotherapy in patients with grade 1 and 2 hypertension not adequately controlled with LCZ monotherapy. The purpose of the OLE part is to assess the long-term safety, tolerability and efficacy of the treatment with LCZ/AML.
対象疾患
Hypertension
介入
LCZ(DRUG)
LCZ/AML 200 mg/2.5 mg(DRUG)
LCZ/AML 200 mg/5 mg(DRUG)
LCZ/AML 200 mg/10 mg(DRUG)
Placebo(OTHER)
依頼者(Sponsor)
ノバルティスファーマ株式会社(INDUSTRY)