Overview

Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2025-12-25

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Amlodipine
sacubitril and valsartan sodium hydrate drug combination