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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171067
• Other study ID #: CVAL489ADE20
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2005
• Last updated: May 15, 2017
• Start date: July 2004
• Est. completion date: May 2007

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan

• lisinopril

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urinary albumin excretion after 30 weeks
Secondary	Change from baseline in blood test for kidney function after 30 weeks
Secondary	Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg
Secondary	Change from baseline in circulating marker of inflammation after 30 weeks

External Links

•   Clinical Trial Results for CVAL489ADE20 at Novartis Clinical Trials.com