Antiproteinuric Effect of Valsartan and Lisinopril
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Diabetic Nephropathy
Intervention: Valsartan (Drug); Valsartan plus HCTZ (Drug); Lisinopril (Drug)
Phase: Phase 4
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
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.
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.
- Immediate need for renal replacement therapy.
- Treatment resistant oedema.
- Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or
- 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.
Locations and Contacts
Novartis Pharmaceuticals, Basel, Switzerland
Starting date: November 2004
Last updated: February 9, 2007