Antiproteinuric Effect of Valsartan and Lisinopril

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171574
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

September 12, 2005
September 15, 2005
February 24, 2017
November 2004
July 2006   (Final data collection date for primary outcome measure)
Change from baseline in urine protein excretion after 20 weeks
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Complete list of historical versions of study NCT00171574 on Archive Site
  • 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
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Antiproteinuric Effect of Valsartan and Lisinopril
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

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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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Hypertension
  • Diabetic Nephropathy
  • Drug: Valsartan
  • Drug: Valsartan plus HCTZ
  • Drug: Lisinopril
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2006
July 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
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Contact information is only displayed when the study is recruiting subjects
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP