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Antiproteinuric Effect of Valsartan and Lisinopril

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Diabetic Nephropathy

Intervention: Valsartan (Drug); Valsartan plus HCTZ (Drug); Lisinopril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in urine protein excretion after 20 weeks

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female outpatients aged 18-70 years, 2. 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. 3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ). 4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg). 5. 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 anti-inflammatory drugs, or

immunosuppressive 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.

Locations and Contacts

Novartis Pharmaceuticals, Basel, Switzerland
Additional Information

Starting date: November 2004
Last updated: November 7, 2011

Page last updated: August 23, 2015

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