Antiproteinuric Effect of Valsartan and Lisinopril - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

February 9, 2007

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in urine protein excretion after 20 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00171574 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in a laboratory measure of kidney function after 20 weeks
Change from baseline in systolic blood pressure after 20 weeks
Change from baseline in diastolic blood pressure after 20 weeks

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Antiproteinuric Effect of Valsartan and Lisinopril

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension
Diabetic Nephropathy

Intervention ^ICMJE

Drug: Valsartan
Drug: Valsartan plus HCTZ
Drug: Lisinopril

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female outpatients aged 18-70 years,
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.
Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimun of three months ).
Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).
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 antiinflammatory drugs, or inmunosupressive 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 mol/L

Other protocol-defined exclusion criteria may apply.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00171574

Responsible Party

Study ID Numbers ^ICMJE

CVAL489AES13

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP