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Antiproteinuric Effect of Valsartan and Lisinopril

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 12, 2005
Last updated: February 22, 2017
Last verified: February 2017

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 Intervention Phase
Diabetic Nephropathy
Drug: Valsartan
Drug: Valsartan plus HCTZ
Drug: Lisinopril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Enrollment: 124
Study Start Date: November 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.

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Please refer to this study by its identifier: NCT00171574

Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00171574     History of Changes
Other Study ID Numbers: CVAL489AES13
Study First Received: September 12, 2005
Last Updated: February 22, 2017

Keywords provided by Novartis:
diabetic nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 21, 2017