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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171067 |
The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).
Condition | Intervention | Phase |
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Hypertension |
Drug: valsartan Drug: lisinopril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Evaluate the Effectiveness of Valsartan 320 mg in Combination With Lisinopril 20 mg Versus Monotherapy With Lisinopril 40 mg or Valsartan 320 mg in Hypertensive Patients With Microalbuminuria on the Reduction of Urinary Albumin Creatinine Ratio |
Estimated Enrollment: | 150 |
Study Start Date: | July 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Evidence of renal impairment as determined by any one of the following:
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CVAL489ADE20 |
Study First Received: | September 10, 2005 |
Last Updated: | November 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00171067 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Microalbuminuria, urinary albumin excretion, urinary albumin creatinine ratio, hypertension, valsartan, lisinopril, combination |
Lisinopril Vascular Diseases Valsartan 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 |