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Antiproteinuric Effect of Valsartan and Lisinopril

Primary Purpose

Hypertension, Diabetic Nephropathy

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Valsartan
Valsartan plus HCTZ
Lisinopril
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring valsartan, lisinopril, antiproteinuric, diabetic nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Novartis Pharmaceuticals

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
February 22, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00171574
Brief Title
Antiproteinuric Effect of Valsartan and Lisinopril
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetic Nephropathy
Keywords
valsartan, lisinopril, antiproteinuric, diabetic nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Type
Drug
Intervention Name(s)
Valsartan plus HCTZ
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Primary Outcome Measure Information:
Title
Change from baseline in urine protein excretion after 20 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in a laboratory measure of kidney function after 20 weeks
Title
Change from baseline in systolic blood pressure after 20 weeks
Title
Change from baseline in diastolic blood pressure after 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland

12. IPD Sharing Statement

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Antiproteinuric Effect of Valsartan and Lisinopril

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