Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
54 participants
INTERVENTIONAL
2005-07-31
2007-01-31
Brief Summary
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Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies..
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Pharmaceuticals
Basel, , Switzerland
Countries
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References
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Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
Other Identifiers
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CVAL489AES15
Identifier Type: -
Identifier Source: org_study_id