Antialbuminuric Effects of Valsartan and Lisinopril
Status:
Terminated
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
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.