NCT00171600

Antialbuminuric Effects of Valsartan and Lisinopril

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Hypertension
• Early Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-15
• Last updated: 2011-11-08

Locations

1 site across 1 country: Switzerland