Status:
TERMINATED
Antialbuminuric Effects of Valsartan and Lisinopril
Lead Sponsor:
Novartis
Conditions:
Hypertension
Early Diabetic Nephropathy
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up....
Eligibility Criteria
Inclusion
- Male or female outpatients aged 40-75 years,
- Chronic nephropathy, as defined by a serum creatinine concentration of \> 1.3 mg/dL or calculated glomerular filtration rate of \> 30 mL/min/1.73 m2.
- Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not \> 1000 mg/ 24h. (for a minimum of three months).
- Hypertensive patients not adequately controlled with or without treatment (controlled: \<130/80 mmHg).
- Written informed consent to participate in the study prior to any study procedures.
Exclusion
- Immediate need for renal replacement therapy.
- Treatment resistant oedema or nephrotic syndrome.
- Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs.
- Albuminuria greater than 1000mg /24h and or less than 20mg/24h.
- Total cholesterol \< 135mg/dl or not need for statins treatment.
- 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 umol/L
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00171600
Start Date
July 1 2005
End Date
January 1 2007
Last Update
November 8 2011
Active Locations (1)
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1
Novartis Pharmaceuticals
Basel, Switzerland