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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:October 2013

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A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

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


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
We found this trial at
4
sites
Glendale, California 91206
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Anaheim, California 92801
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Anaheim, CA
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Cypress, California 90630
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Hong Kong, Shatin, NT
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Hong Kong,
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