Hypertension Clinical Trial
Official title:
Comparative, Open Multicenter Trial Assessing the Effect on Albumin Excretion Rate of 320mg Valsartan (With or Without HCTZ) vs 40mg Lisinopril (With or Without HCTZ) on Hypertensive Patients With Diabetic and Non-diabetic Nephropathy and Albuminuria
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in
non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group,
20 weeks follow-up.
Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril
vs combo treatment in non-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more
than monotherapies..
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan
versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of
follow-up. Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with
valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to
investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus
lisinopril on blood pressure and the effect on left ventricular mass index using
electrocardiogram and Cornell-Sokolow method.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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