Antiproteinuric Effect of Valsartan and Lisinopril

Condition(s) targeted: Hypertension; Diabetic Nephropathy

Intervention: Valsartan (Drug); Valsartan plus HCTZ (Drug); Lisinopril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in urine protein excretion after 20 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 minimun 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 antiinflammatory drugs, or

inmunosupressive 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 mol/L

Other protocol-defined exclusion criteria may apply.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: November 2004
Last updated: February 9, 2007