Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

Novartis

Status and phase: Completed; Phase 2

Conditions: Salt-sensitive Hypertension

Treatments: Drug: Valsartan; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681576

CLCZ696A2222

Details and patient eligibility

About

This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Written informed consent must be obtained before any study assessment is performed.
• Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
• Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.

Key Exclusion Criteria:

• Women of child-bearing potential.
• History of angioedema, drug-related or otherwise
• History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
• Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
• History or evidence of a secondary form of hypertension,
• Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
• History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
• Current or history of hypertensive retinopathy.
• Previous or current diagnosis of heart failure (NYHA Class II-IV).
• Clinically significant valvular heart disease at screening.

Other protocol defined inclusion/exclusion criteria may apply

Trial design

72 participants in 2 patient groups

LCZ696 followed by Valsartan

Experimental group

Description:

Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks

Treatment:

Drug: Valsartan

Drug: LCZ696

Valsartan followed by LCZ696

Experimental group

Description:

Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks

Treatment:

Drug: Valsartan

Drug: LCZ696