Antialbuminuric Effects of Valsartan and Lisinopril

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171600
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in urine albumin excretion rate from collected urine samples, after 16 and 20 weeks

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171600

Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Identifier: NCT00171600     History of Changes
Other Study ID Numbers: CVAL489AES15
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
diabetic nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs