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Antiproteinuric Effect of Valsartan and Lisinopril

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ClinicalTrials.gov Identifier: NCT00171574
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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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


Condition or disease Intervention/treatment Phase
Hypertension Diabetic Nephropathy Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in urine protein excretion after 20 weeks

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171574


Locations
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Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171574    
Other Study ID Numbers: CVAL489AES13
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis:
valsartan
lisinopril
antiproteinuric
diabetic nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Valsartan
Lisinopril
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