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NCT00171561 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171561
Other study ID # CVAH631B2404
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated November 7, 2011
Start date March 2003
Est. completion date September 2006

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan/hydrochlorothiazide

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood measures of hypertension after 24 weeks
Secondary Blood measures of hypertension in arterial system after 24 weeks
Secondary Change in protein excretion rate after 24 weeks
Secondary Change in serum markers of endothelial function and oxidative stress after 24 weeks
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