Hypertension Clinical Trial
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 p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
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.
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.
Comparison(s):
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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