Hypertension Clinical Trial
Official title:
Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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