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| Sponsored by: |
Novartis |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00171574 |
Purpose
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 |
| MedlinePlus related topics: | Diabetic Kidney Problems High Blood Pressure |
| Drug Information available for: | Lisinopril Valsartan |
| 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 |
Eligibility
| 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.
Contacts and Locations
More Information
| Study ID Numbers: | CVAL489AES13 |
| First Received: | September 12, 2005 |
| Last Updated: | February 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00171574 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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