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| Sponsor: | Novartis |
|---|---|
| Information provided by (Responsible Party): | Novartis |
| ClinicalTrials.gov Identifier: | NCT00171067 |
Purpose
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 |
|---|---|---|
|
Hypertension |
Drug: valsartan Drug: lisinopril |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Enrollment: | 134 |
| Study Start Date: | July 2004 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Eligibility| 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.
Contacts and Locations
More Information
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00171067 History of Changes |
| Other Study ID Numbers: | CVAL489ADE20 |
| Study First Received: | September 10, 2005 |
| Last Updated: | November 7, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Microalbuminuria, urinary albumin excretion, urinary albumin creatinine ratio, hypertension, valsartan, lisinopril, combination |
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Hypertension Albuminuria Vascular Diseases Cardiovascular Diseases Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Lisinopril Valsartan Angiotensin-Converting Enzyme Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Cardiotonic Agents Protective Agents Physiological Effects of Drugs Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |