Antialbuminuric Effects 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; Early Diabetic Nephropathy
Intervention: VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ (Drug)
Phase: Phase 4
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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
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.
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Minimum age: 40 Years.
Maximum age: 75 Years.
- 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:
- Written informed consent to participate in the study prior to any study procedures.
- Immediate need for renal replacement therapy.
- Treatment resistant oedema or nephrotic syndrome.
- Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or
- 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 mol/L
Locations and Contacts
Novartis Pharmaceuticals, Basel, Switzerland
Starting date: July 2005
Last updated: April 23, 2007