drugset / Trial / NCT06236061
Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2024-04-08
- Primary completion
- 2025-05-28
- Completion
- 2025-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 2.5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |
| Comparator | LCZ | Unknown | 200 mg | Oral |