Hypertension
Conditions
Keywords
Microalbuminuria, urinary albumin excretion, urinary albumin creatinine ratio, hypertension, valsartan, lisinopril, combination
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).
Interventions
DRUGvalsartan
DRUGlisinopril
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urinary albumin excretion after 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany, Switzerland
Outcome results
None listed