Antiproteinuric Effect of Valsartan and Lisinopril
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|ClinicalTrials.gov Identifier: NCT00171574|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 24, 2017
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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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetic Nephropathy||Drug: Valsartan Drug: Valsartan plus HCTZ Drug: Lisinopril||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||November 2004|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- Change from baseline in urine protein excretion after 20 weeks
- 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
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Male or female outpatients aged 18-70 years,
- 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.
- Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
- Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).
- Written informed consent to participate in the study prior to any study procedures.
- 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 ümol/L
Other protocol-defined exclusion criteria may apply.
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 ClinicalTrials.gov identifier (NCT number): NCT00171574
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||September 15, 2005 Key Record Dates|
|Last Update Posted:||February 24, 2017|
|Last Verified:||February 2017|
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