NCT00274144

Inflammation and Coronary Artery Disease: Role of AT1-Receptor Antagonism

Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (planned)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure

Detailed description

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

Conditions

• Hypertension
• Coronary Arteriosclerosis

Interventions

Type	Name	Description
DRUG	telmisartan 40 mg
DRUG	placebo 40 mg

Timeline

• Start date: 2001-12-01
• Primary completion: 2004-03-01
• Completion: 2004-05-01
• First posted: 2006-01-10
• Last updated: 2013-11-01

Locations

1 site across 1 country: Germany