Status:
COMPLETED
Antiproteinuric Effect of Valsartan and Lisinopril
Lead Sponsor:
Novartis
Conditions:
Hypertension
Diabetic Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00171574
Start Date
November 1 2004
End Date
July 1 2006
Last Update
February 24 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
Basel, Switzerland