Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240422
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2005-10-14
Brief Title:
Trial to Compare the Effects of Either Telmisartan 40-80 mg PO Once Daily or Ramipril 5-10 mg PO Once Daily on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Prospective Randomized Double-blind Double-dummy Forced Titration Parallel Group Comparison Multicenter Trial to Compare the Effects of Either Telmisartan 40-80 mg po Once Daily or Ramipril 5-10 mg po Once Daily on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
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 primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature measured as renal plasma flow RPF in response to NG-monomethyl-L-arginine LNMMA infusion
Detailed Description:
This study was designed as a randomised double-blind double-dummy parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks
After a 4 week Run-in period patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment During the treatment period 3 visits to the investigator will be scheduled in order to control blood pressure renal function parameters and safety In addition parameters of endothelial function in the renal vasculature based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment
Study Hypothesis
Due to the exploratory nature of the trial the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses
Comparisons
The change in RPF from baseline Visit 4 to the end of treatment Visit 7 in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion S1 to the end of the L-NMMA infusion S2 A comparison of treatment groups was to be made using an analysis of covariance ANCOVA with pooled centre and treatment included as main effects and RPF in response to L NMMA infusion at baseline as a covariate The treatment group difference adjusted for the other factors in the model was to be presented with a corresponding 95 confidence interval CI and a test of statistical significance The model was also to be used to provide analysis results for the within treatment group changes
After a 4 week Run-in period patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment During the treatment period 3 visits to the investigator will be scheduled in order to control blood pressure renal function parameters and safety In addition parameters of endothelial function in the renal vasculature based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment
Study Hypothesis
Due to the exploratory nature of the trial the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses
Comparisons
The change in RPF from baseline Visit 4 to the end of treatment Visit 7 in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion S1 to the end of the L-NMMA infusion S2 A comparison of treatment groups was to be made using an analysis of covariance ANCOVA with pooled centre and treatment included as main effects and RPF in response to L NMMA infusion at baseline as a covariate The treatment group difference adjusted for the other factors in the model was to be presented with a corresponding 95 confidence interval CI and a test of statistical significance The model was also to be used to provide analysis results for the within treatment group changes
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