Antialbuminuric Effects of Valsartan and Lisinopril
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.
|Hypertension Early Diabetic Nephropathy||Drug: VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Change from baseline in urine albumin excretion rate from collected urine samples, after 16 and 20 weeks
- Blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
- Change from baseline 48-hour ambulatory blood pressure, and blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
- Blood pressure less than 130/80 mmHg at night, measured by 48-hour ambulatory blood pressure monitoring, after 16 and 20 weeks of treatment
- Change from baseline in size of left heart ventricle by electrocardiogram (ECG) after 20 weeks
- Change from baseline in kidney function after 16 and 20 weeks
|Study Start Date:||July 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171600
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|