Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171561
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood measures of hypertension after 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland