Antiproteinuric Effect of Valsartan and Lisinopril

NCT ID: NCT00171574

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-07-31

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

Conditions

Hypertension; Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Valsartan

Intervention Type: DRUG

Valsartan plus HCTZ

Intervention Type: DRUG

Lisinopril

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

CVAL489AES13

Identifier Type: -

Identifier Source: org_study_id