Antialbuminuric Effects of Valsartan and Lisinopril

NCT00171600 | Terminated Phase 4

• 1 other identifier: CVAL489AES15
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Early Diabetic Nephropathy

Keywords

valsartan; lisinopril; albuminuria; diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

• Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

  PMID: 38682786 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetic Nephropathies; Albuminuria

Interventions

Valsartan; Hydrochlorothiazide; Lisinopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dipeptides; Oligopeptides; Peptides

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

CH (1)