Antialbuminuric Effects of Valsartan and Lisinopril - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171600

Purpose

Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up.

Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies..

Design: Multicentric, randomized, open label, parallel group, active controlled.

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

Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks.

Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.

Condition	Intervention	Phase
Hypertension Early Diabetic Nephropathy	Drug: VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ	Phase IV

MedlinePlus related topics: Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Lisinopril Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparative, Open Multicenter Trial Assessing the Effect on Albumin Excretion Rate of 320mg Valsartan (With or Without HCTZ) vs 40mg Lisinopril (With or Without HCTZ) on Hypertensive Patients With Diabetic and Non-Diabetic Nephropathy and Albuminuria

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in urine albumin excretion rate from collected urine samples, after 16 and 20 weeks

Secondary Outcome Measures:

Blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Change from baseline 48-hour ambulatory blood pressure, and blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Blood pressure less than 130/80 mmHg at night, measured by 48-hour ambulatory blood pressure monitoring, after 16 and 20 weeks of treatment
Change from baseline in size of left heart ventricle by electrocardiogram (ECG) after 20 weeks
Change from baseline in kidney function after 16 and 20 weeks

Estimated Enrollment:	201
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male or female outpatients aged 40-75 years,
Chronic nephropathy, as defined by a serum creatinine concentration of > 1.3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.
Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not > 1000 mg/ 24h. (for a minimum of three months).
Hypertensive patients not adequately controlled with or without treatment (controlled: <130/80 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 or nephrotic syndrome.
Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs.
Albuminuria greater than 1000mg /24h and or less than 20mg/24h.
Total cholesterol < 135mg/dl or not need for statins treatment.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171600

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CVAL489AES15
Study First Received:	September 12, 2005
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00171600
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

valsartan
lisinopril
albuminuria
diabetic nephropathy

Study placed in the following topic categories:

Diabetic Nephropathies
Albuminuria
Lisinopril
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Hydrochlorothiazide

Urologic Diseases
Kidney Diseases
Endocrinopathy
Diabetes Complications
Valsartan
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Protective Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009