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 Unknown 160 mg —
Subject Valsartan Unknown 320 mg —
Background Hydrochlorothiazide Unknown — —