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OpenTrials
Completed

NCT Number: NCT00171574

Antiproteinuric Effect of Valsartan and Lisinopril

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

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

valsartan

Drug

Valsartan plus HCTZ

Drug

Lisinopril

Drug

Primary outcomes

  1. Change from baseline in urine protein excretion after 20 weeks

Secondary outcomes

  1. Change from baseline in a laboratory measure of kidney function after 20 weeks

  2. Change from baseline in systolic blood pressure after 20 weeks

  3. Change from baseline in diastolic blood pressure after 20 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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