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 di
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Hypertension
Intervention: Telmisartan (Drug); Ramipril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Pharma GmbH & Co. KG
Summary
The primary objective was 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..
Clinical Details
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 di
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion
Secondary outcome: Change from baseline in
Renal function parameters before and in response to L-NMMA and L-arginine hydrochloride infusion;
angiotensin II, aldosterone, ADMA, L-arginine
urinary excretion parameters
blood pressure, augmentation index
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 weeks Run-in period, patients were 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 perid summing up to 9 weeks of treatment. During the
treatment period, 3 visits to the investigator were scheduled in order to control blood
pressure, renal function parameters and safety. In addition, parameters of endothelial
function in the rebal vaculature, based on a nephrological clearance investigation and a
provocation with L-NMMA were 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.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or
microalbuminuria, GFR > 80 mL/min (Cockroft-Gault)
Locations and Contacts
Boehringer Ingelheim Investigational Site, Montpellier, France
Boehringer Ingelheim Investigational Site, Lyon, France
Friedrich-Alexander-Universität, Erlangen 91054, Germany
Universität Erlangen-Nürnberg, Nürnberg 90471, Germany
Boehringer Ingelheim Investigational Site, Nürnberg 90402, Germany
Edificio de Medicina Comunitaria, Madrid 28041, Spain
Additional Information
Starting date: February 2003
Ending date: July 2004
Last updated: April 3, 2008
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