Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274144
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Inflammation and Coronary Artery Disease Role of AT1-Receptor Antagonism
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Pilot Study Inflammation and Coronary Artery Disease Role of AT1 Receptor Antagonism
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Plannedactual number of subjects
Enrolled 4050 randomised 4042 completed 4042
Diagnosis and main criteria for inclusion
Treated essential hypertension with a mean seated DBPSBP smaller than 95 mmHg160 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
Comparisons
Placebo 40 mg
Randomised double-blind and placebo-controlled parallel group design
Plannedactual number of subjects
Enrolled 4050 randomised 4042 completed 4042
Diagnosis and main criteria for inclusion
Treated essential hypertension with a mean seated DBPSBP smaller than 95 mmHg160 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
Comparisons
Placebo 40 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None