Antiproteinuric Effect of Valsartan and Lisinopril
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
|Hypertension Diabetic Nephropathy||Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
|Official Title:||Antiproteinuric Effect of Valsartan, Lisinopril and Valsartan Plus Lisinopril in Non-diabetic and Diabetic Renal Disease: a Randomized, Double Blind, Parallel Group, Controlled Trial With 5 Months Follow-up|
- Change from baseline in urine protein excretion after 20 weeks
- Change from baseline in a laboratory measure of kidney function after 20 weeks
- Change from baseline in systolic blood pressure after 20 weeks
- Change from baseline in diastolic blood pressure after 20 weeks
|Study Start Date:||November 2004|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171574
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|