VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Change from baseline in urinary albumin excretion after 30 weeks []
Secondary Outcome Measures
- Change from baseline in blood test for kidney function after 30 weeks []
- Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg []
- Change from baseline in circulating marker of inflammation after 30 weeks []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with mild to moderate hypertension with a mean sitting diastolic blood pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until < 2 days prior to Visit 1
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Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
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Confirmation of MAU of at least 2 out of 3 measurements determined in the first morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day -7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5 mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0 mg/mmol at both visits.
Exclusion Criteria:
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Evidence of renal impairment as determined by any one of the following:
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serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault formula [Cockroft and Gault, 1976] and/or
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serum creatinine > 1.25 x ULN at Visit 1,
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a history of dialysis, or
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a history of nephrotic syndrome.
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Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
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Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Centers | Germany | |||
| 2 | Novartis Pharmaceuticals | Basel | Switzerland |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVAL489ADE20