Antiproteinuric Effect of Valsartan and Lisinopril

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Lisinopril; Valsartan

Criteria

Inclusion Criteria:

1. Male or female outpatients aged 18-70 years,

2. Chronic nephropathy, as defined by a serum creatinine concentration of > 3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.

3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).

4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).

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

Exclusion Criteria

• Immediate need for renal replacement therapy.

• Treatment resistant oedema.

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

• Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.

• 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 ümol/L

Other protocol-defined exclusion criteria may apply.