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

Novartis

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: valsartan/hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171561

CVAH631B2404

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.