Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

Novartis144 enrolled

Overview

The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

144

Conditions

Hypertension

Interventions

valsartan/hydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * type 2 diabetes * elevated blood pressure and pulse pressure * albuminuria Exclusion Criteria: * Severe hypertension * History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * Liver, kidney (not caused by diabetes), or pancreas disease * Type 1 diabetes or uncontrolled type 2 diabetes * Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Blood measures of hypertension after 24 weeks

Secondary Outcomes

Blood measures of hypertension in arterial system after 24 weeks

Change in protein excretion rate after 24 weeks

Change in serum markers of endothelial function and oxidative stress after 24 weeks

Data from ClinicalTrials.gov

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