VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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).
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
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
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.
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.