Antialbuminuric Effects of Valsartan and Lisinopril - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

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 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

Enrollment:	54
Study Start Date:	July 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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 umol/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

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171600 History of Changes
Other Study ID Numbers:	CVAL489AES15
Study First Received:	September 12, 2005
Last Updated:	November 7, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

valsartan
lisinopril
albuminuria
diabetic nephropathy

Additional relevant MeSH terms:

Diabetic Nephropathies
Hypertension
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Lisinopril
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 12, 2012