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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00274144 |
Purpose
Cardiovascular diseases, especially coronary artery disease, are the most common cause for death in industrialized nations. In coronary artery disease endothelial cell damage and an increased number of monocytes/macrophages and T lymphocytes infiltrating the arterial wall form atherosclerotic lesions. Furthermore, an enhanced migration and proliferation of vascular smooth muscle cells can be demonstrated in the early stages of atherosclerosis. In this process inflammatory events contribute to the progression of atherosclerotic lesions and to the development of unstable plaques. In atherogenesis and especially in unstable rupturing plaques the renin angiotensin system is of considerable significance. In atherosclerotic lesions ACE and AT1 receptor expression is upregulated influencing not only endothelial cells but also macrophages and lymphocytes. ACE inhibition and AT1 receptor antagonism are accompanied by a marked reduction of atherogenesis.
The aim of this trial is to assess the efficacy and tolerability of telmisartan (Micardis®, Germany) after one dose daily in patients with hypertension and coronary heart disease. This investigation is intended to test not only the effect on the blood pressure but also whether telmisartan has any effect on inflammatory parameters associated with coronary heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Coronary Arteriosclerosis |
Drug: telmisartan 40 mg Drug: placebo 40 mg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | May 2004 |
Methodology:
Randomised, double-blind and placebo-controlled parallel group design
Planned/actual number of subjects:
Enrolled: 40/50 randomised: 40/42 completed: 40/42
Diagnosis and main criteria for inclusion:
Treated essential hypertension with a mean seated DBP/SBP smaller than 95 mmHg/160 mmHg, coronary artery disease confirmed by catheterization and age equal or greater than 18 years of age.
Duration of treatment:
12 weeks: telmisartan 40 mg or placebo 40 mg
Study Hypothesis:
The statistical null hypothesis is that in patients with CAD and mild-to-moderate hypertension, a 84-day therapy with 40 mg telmisartan causes changes in inflammatory and leukocyte adhesion parameters. The alternative hypothesis is that this therapy does not influence inflammatory and leukocyte adhesion parameters. This hypothesis is tested by the nonparametric Wilcoxon test for unpaired samples.
Comparison(s):
Placebo 40 mg
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations| Germany | |
| Universitätsklinik des Saarlandes | |
| Homburg/Saar, Germany, 66421 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
More Information
| Study ID Numbers: | 502.385 |
| Study First Received: | January 9, 2006 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00274144 History of Changes |
| Health Authority: | Germany: BfArM Bundesinstitut für Arzneimittel und Medizinprodukte |
|
Arterial Occlusive Diseases Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Vascular Diseases Enzyme Inhibitors Arteriosclerosis Pharmacologic Actions Protease Inhibitors |
Inflammation Coronary Disease Angiotensin II Type 1 Receptor Blockers Pathologic Processes Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Coronary Artery Disease Hypertension |