Clinical trial NCT00171067: VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Microalbuminuria, urinary albumin excretion, urinary albumin creatinine ratio, hypertension, valsartan, lisinopril, combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in urinary albumin excretion after 30 weeks
Secondary outcomes:
measure: Change from baseline in blood test for kidney function after 30 weeks
measure: Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg
measure: Change from baseline in circulating marker of inflammation after 30 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Menne J, Farsang C, Deak L, Klebs S, Meier M, Handrock R, Sieder C, Haller H. Valsartan in combination with lisinopril versus the respective high dose monotherapies in hypertensive patients with microalbuminuria: the VALERIA trial. J Hypertens. 2008 Sep;26(9):1860-7. doi: 10.1097/HJH.0b013e32830508aa.