drugset / Trial / NCT00171574

Antiproteinuric Effect of Valsartan and Lisinopril

NCT00171574

Phase 4 Completed 124 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up. Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients. Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies. Design: Multicentric, randomized, double blind, parallel group, active controlled. Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Timeline

Start
2004-11
Primary completion
2006-07
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject LISINOPRIL ANHYDROUS Small molecule 20 mg
Subject LISINOPRIL ANHYDROUS Small molecule 40 mg
Subject Valsartan Small molecule 160 mg
Subject Valsartan Small molecule 320 mg
Background Hydrochlorothiazide Unknown