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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00240422 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Hypertension |
Drug: Telmisartan Drug: Ramipril |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 95 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | July 2004 |
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.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: None
France | |
Boehringer Ingelheim Investigational Site | |
Montpellier, France | |
Boehringer Ingelheim Investigational Site | |
Lyon, France | |
Germany | |
Friedrich-Alexander-Universität | |
Erlangen, Germany, 91054 | |
Universität Erlangen-Nürnberg | |
Nürnberg, Germany, 90471 | |
Boehringer Ingelheim Investigational Site | |
Nürnberg, Germany, 90402 | |
Spain | |
Edificio de Medicina Comunitaria | |
Madrid, Spain, 28041 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
Study ID Numbers: | 502.398 |
Study First Received: | October 14, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00240422 History of Changes |
Health Authority: | Germany: Bundesagentur für Arzneimittel und Medizinprodukte; France: Ministere charge de la sante; Spain: Ministerio de sanidad y consumo, subdirecciòn general de medicamentos de uso humano |
Metabolic Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Cardiovascular Agents Angiotensin II Antihypertensive Agents Ramipril Protease Inhibitors |
Angiotensin II Type 1 Receptor Blockers Diabetes Mellitus, Type 2 Angiotensin-Converting Enzyme Inhibitors Endocrinopathy Telmisartan Glucose Metabolism Disorders Metabolic Disorder Hypertension |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus Vascular Diseases Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Ramipril |
Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Diabetes Mellitus, Type 2 Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Glucose Metabolism Disorders Hypertension |