Hypertension
Conditions
Keywords
hypertension, diabetes, albuminuria, valsartan, hydrochlorothiazide, amlodipine
Brief 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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood measures of hypertension after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Switzerland
Outcome results
None listed