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Antiproteinuric Effect of Valsartan and Lisinopril

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Novartis

Status and phase

Completed
Phase 4

Conditions

Diabetic Nephropathy
Hypertension

Treatments

Drug: Valsartan
Drug: Valsartan plus HCTZ
Drug: Lisinopril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171574
CVAL489AES13

Details and patient eligibility

About

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

Enrollment

124 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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