OncRef

Clinical Trial: NCT06236061

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-01-13

Study Overview

Brief 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.

Official Title

A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696/Amlodipine 200/2.5 mg, 200/5 mg and 200/10 mg Compared to LCZ696 200 mg Alone in Patients With Grade 1 and 2 Hypertension Not Adequately Controlled by LCZ696 200 mg Monotherapy

Conditions

Hypertension

Intervention / Treatment

  • Drug: LCZ
  • Drug: LCZ/AML 200 mg/2.5 mg
  • Drug: LCZ/AML 200 mg/5 mg
  • Drug: LCZ/AML 200 mg/10 mg
  • Other: Placebo

Other Study ID Numbers

  • CLAZ696B11302

Start Date (Actual)

2024-04-08

Primary Completion Date (Actual)

2025-05-28

Study Completion Date (Actual)

2025-12-23

Enrollment (Actual)

718

Study Type

Interventional

Phase

Phase 3