VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug); lisinopril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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).

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in urinary albumin excretion after 30 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: July 2004
Last updated: November 7, 2007