Antialbuminuric Effects of Valsartan and Lisinopril

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Lisinopril; Valsartan

Criteria

Inclusion Criteria:

• Male or female outpatients aged 40-75 years,

• Chronic nephropathy, as defined by a serum creatinine concentration of > 1.3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.

• Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not > 1000 mg/ 24h. (for a minimum of three months).

• Hypertensive patients not adequately controlled with or without treatment (controlled:

<130/80 mmHg).

• Written informed consent to participate in the study prior to any study procedures.

Exclusion Criteria:

• Immediate need for renal replacement therapy.

• Treatment resistant oedema or nephrotic syndrome.

• Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs.

• Albuminuria greater than 1000mg /24h and or less than 20mg/24h.

• Total cholesterol < 135mg/dl or not need for statins treatment.

• Renovascular hypertension

• Malignant hypertension

• MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.

• Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.

• A serum creatinine concentration >265 umol/L