Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00153023
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2005-09-09
Brief Title:
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Prospective Randomised Double-blind Double-dummy Forced-titration Multicentre Parallel Group One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 13080 mmHg after one year of treatment
The primary objective of this study is to show that telmisartan 80 mg is at least as effective ie not inferior and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment
The primary objective of this study is to show that telmisartan 80 mg is at least as effective ie not inferior and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment
Detailed Description:
This is a randomised double-blind double-dummy forced titration multicentre parallel group trial in patients with essential hypertension diabetes mellitus type 2 and diabetic nephropathy
After a 4-6 week Run-in period patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment During the treatment period 8 visits to the investigator are scheduled in order to control blood pressure renal function parameters and safety In addition parameters of endothelial function and oxidative stress are measured at baseline 6 months and after one year of treatment
Study Hypothesis
Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses
Null Hypothesis
The overall mean change from baseline in UPER 24 hour urinary protein excretion rate for telmisartan 80 mg is inferior to that for valsartan 160 mg by 05 gday or more
Alternative Hypothesis
The overall mean change from baseline in UPER 24 hour urinary protein excretion rate for telmisartan 80 mg is less than 05 gday worse than that for valsartan 160 mg
Comparisons
In order to test the non-inferiority hypothesis analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed Time-to-event data will be analysed using the log-rank test
After a 4-6 week Run-in period patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment During the treatment period 8 visits to the investigator are scheduled in order to control blood pressure renal function parameters and safety In addition parameters of endothelial function and oxidative stress are measured at baseline 6 months and after one year of treatment
Study Hypothesis
Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses
Null Hypothesis
The overall mean change from baseline in UPER 24 hour urinary protein excretion rate for telmisartan 80 mg is inferior to that for valsartan 160 mg by 05 gday or more
Alternative Hypothesis
The overall mean change from baseline in UPER 24 hour urinary protein excretion rate for telmisartan 80 mg is less than 05 gday worse than that for valsartan 160 mg
Comparisons
In order to test the non-inferiority hypothesis analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed Time-to-event data will be analysed using the log-rank test
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