Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00171600
Status:
TERMINATED
Last Update Posted:
2011-11-08
First Post:
2005-09-12
Brief Title:
Antialbuminuric Effects of Valsartan and Lisinopril
Sponsor:
Novartis
Organization:
Novartis
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Title Antialbuminuric effect of valsartan lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease a randomized 331 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 albumincreatinine ratio more than monotherapies
Design Multicentric randomized open label parallel group active controlled
Dose regimen Valsartan 320 vs Lisinopril 40 vs Valsartanlisinopril 16020
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 valsartanlisinopril 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
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 albumincreatinine ratio more than monotherapies
Design Multicentric randomized open label parallel group active controlled
Dose regimen Valsartan 320 vs Lisinopril 40 vs Valsartanlisinopril 16020
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 valsartanlisinopril 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None