Antiproteinuric Effect of Valsartan and Lisinopril

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171574

Collaborator

(none)

124

Enrollment

Location

19.9

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetic Nephropathy	Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Change from baseline in urine protein excretion after 20 weeks []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Male or female outpatients aged 18-70 years,
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.
Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).
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