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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

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