VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171067
- Lead Sponsor
- Novartis
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
- 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
- Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
- 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
-
Evidence of renal impairment as determined by any one of the following:
- serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault formula [Cockroft and Gault, 1976] and/or
- serum creatinine > 1.25 x ULN at Visit 1,
- a history of dialysis, or
- a history of nephrotic syndrome.
-
Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
-
Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in urinary albumin excretion after 30 weeks
- Secondary Outcome Measures
Name Time Method Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg Change from baseline in blood test for kidney function after 30 weeks Change from baseline in circulating marker of inflammation after 30 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland