Clinical Trial: Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: Novartis
Current Primary Outcome: Blood measures of hypertension after 24 weeks
Original Primary Outcome:
Current 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
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 12, 2005
Date Started: March 2003
Date Completion:
Last Updated: November 7, 2011
Last Verified: November 2011
