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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: valsartan/hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


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.

Clinical Details

Official title: A 24-week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Blood measures of hypertension after 24 weeks

Secondary outcome:

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


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


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


- 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 and Contacts

Novartis Pharmaceuticals, Basel, Switzerland
Additional Information

Starting date: March 2003
Last updated: November 7, 2011

Page last updated: August 23, 2015

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