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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171600 |
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.
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension Early Diabetic Nephropathy |
Drug: VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative, Open Multicenter Trial Assessing the Effect on Albumin Excretion Rate of 320mg Valsartan (With or Without HCTZ) vs 40mg Lisinopril (With or Without HCTZ) on Hypertensive Patients With Diabetic and Non-Diabetic Nephropathy and Albuminuria |
Estimated Enrollment: | 201 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CVAL489AES15 |
Study First Received: | September 12, 2005 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00171600 |
Health Authority: | Spain: Spanish Agency of Medicines |
valsartan lisinopril albuminuria diabetic nephropathy |
Diabetic Nephropathies Albuminuria Lisinopril Diabetes Mellitus Vascular Diseases Endocrine System Diseases Hydrochlorothiazide |
Urologic Diseases Kidney Diseases Endocrinopathy Diabetes Complications Valsartan Hypertension |
Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Protective Agents Pharmacologic Actions Protease Inhibitors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |