Antiproteinuric Effect of Valsartan and Lisinopril

Hypertension Clinical Trial

Official title:

Antiproteinuric Effect of Valsartan, Lisinopril and Valsartan Plus Lisinopril in Non-diabetic and Diabetic Renal Disease: a Randomized, Double Blind, Parallel Group, Controlled Trial With 5 Months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171574
• Other study ID #: CVAL489AES13
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 22, 2017
• Start date: November 2004
• Est. completion date: July 2006

Study information

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

Clinical Trial Summary

Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up.

Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.

Design: Multicentric, randomized, double blind, parallel group, active controlled.

Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female outpatients aged 18-70 years,

2. Chronic nephropathy, as defined by a serum creatinine concentration of > 3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.

3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).

4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).

5. Written informed consent to participate in the study prior to any study procedures.

Exclusion Criteria

• Immediate need for renal replacement therapy.

• Treatment resistant oedema.

• Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs.

• Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.

• Renovascular hypertension

• Malignant hypertension

• MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.

• Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.

• A serum creatinine concentration >265 ümol/L

Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Hypertension
• Kidney Diseases

Intervention

Drug:
• Valsartan

• Valsartan plus HCTZ

• Lisinopril

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine protein excretion after 20 weeks
Secondary	Change from baseline in a laboratory measure of kidney function after 20 weeks
Secondary	Change from baseline in systolic blood pressure after 20 weeks
Secondary	Change from baseline in diastolic blood pressure after 20 weeks

External Links

•   Results for CVAL489AES13 from the Novartis Clinical Trials website