Status:
COMPLETED
VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00171067
Start Date
July 1 2004
End Date
May 1 2007
Last Update
May 17 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland