Inflammation and Coronary Artery Disease: Role of AT1-Receptor Antagonism
|Hypertension Coronary Arteriosclerosis||Drug: telmisartan 40 mg Drug: placebo 40 mg||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism|
- Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1
- Alterations of clinical parameters such as clinical outcome, and changes in blood pressure. Safety and tolerability in terms of incidence and severity of adverse events, changes in physical examination, heart rate, laboratory parameters, and 12-lead-ECG.
|Study Start Date:||December 2001|
|Estimated Study Completion Date:||May 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
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
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.
Placebo 40 mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274144
|Universitätsklinik des Saarlandes|
|Homburg/Saar, Germany, 66421|
|Study Chair:||Boehringer Ingelheim Study Coordinator||B.I. Pharma GmbH & Co. KG|