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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171574 |
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
Condition | Intervention | Phase |
---|---|---|
Hypertension Diabetic Nephropathy |
Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 140 |
Study Start Date: | November 2004 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CVAL489AES13 |
Study First Received: | September 12, 2005 |
Last Updated: | February 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00171574 |
Health Authority: | Spain: Spanish Agency of Medicines |
valsartan lisinopril antiproteinuric diabetic nephropathy |
Diabetic Nephropathies Urologic Diseases Lisinopril Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Valsartan Diabetes Complications Hypertension |
Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Therapeutic Uses Physiological Effects of Drugs Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Protective Agents Pharmacologic Actions Protease Inhibitors |