Antiproteinuric Effect of Valsartan and Lisinopril - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171574

Purpose

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

Condition	Intervention	Phase
Hypertension Diabetic Nephropathy	Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Lisinopril Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in urine protein excretion after 20 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:	140
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171574

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAL489AES13
Study First Received:	September 12, 2005
Last Updated:	February 9, 2007
ClinicalTrials.gov Identifier:	NCT00171574 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

valsartan
lisinopril
antiproteinuric
diabetic nephropathy

Additional relevant MeSH terms:

Diabetic Nephropathies
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Lisinopril
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Protective Agents
Pharmacologic Actions
Protease Inhibitors
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Kidney Diseases
Diabetes Complications
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 25, 2009