Antiproteinuric Effect of Valsartan and Lisinopril

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171574

Enrollment

124

Registered

2005-09-15

Start date

2004-11-30

Completion date

2006-07-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Hypertension

Keywords

valsartan, lisinopril, antiproteinuric, diabetic nephropathy

Brief 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

Interventions

DRUGValsartan plus HCTZ

DRUGLisinopril

DRUGValsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in urine protein excretion after 20 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026