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

Primary Purpose

Hypertension, Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
telmisartan 40 mg
placebo 40 mg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline) Coronary artery disease confirmed by cardiac catheterization > 18 years of age Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period. Ability to provide written informed consent. Exclusion Criteria: Acute coronary syndromes. Acute or chronic heart failure (left ventricular ejection fraction < 45 %). Symptomatic valvular heart disease. Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis). Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who: Are not surgically sterile. Are nursing. Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives. Known or suspected secondary hypertension. Mean sitting SBP > 160 mm Hg or mean sitting DBP > 95 mm Hg during any visit. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > than 2 times the upper limit of normal range . Serum creatinine > 2.3 mg/dL. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney. Clinically relevant hypokalaemia or hyperkalaemia. Uncorrected volume depletion. Uncorrected sodium depletion. Primary aldosteronism. Hereditary fructose intolerance. Biliary obstructive disorders. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists. History of drug or alcohol dependency within 6 months. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (cf. 4.2.1). Current participation in another trial, or participation in a trial within a period of one month. Known hypersensitivity to any component of the formulation. Has no contra-indication to a placebo run-in period (e.g., recent stroke or MI). Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan.

Sites / Locations

  • Universitätsklinik des Saarlandes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274144
Brief Title
Inflammation and Coronary Artery Disease: Role of AT1-Receptor Antagonism
Official Title
Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Coronary Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
telmisartan 40 mg
Intervention Type
Drug
Intervention Name(s)
placebo 40 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline) Coronary artery disease confirmed by cardiac catheterization > 18 years of age Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period. Ability to provide written informed consent. Exclusion Criteria: Acute coronary syndromes. Acute or chronic heart failure (left ventricular ejection fraction < 45 %). Symptomatic valvular heart disease. Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis). Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who: Are not surgically sterile. Are nursing. Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives. Known or suspected secondary hypertension. Mean sitting SBP > 160 mm Hg or mean sitting DBP > 95 mm Hg during any visit. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > than 2 times the upper limit of normal range . Serum creatinine > 2.3 mg/dL. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney. Clinically relevant hypokalaemia or hyperkalaemia. Uncorrected volume depletion. Uncorrected sodium depletion. Primary aldosteronism. Hereditary fructose intolerance. Biliary obstructive disorders. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists. History of drug or alcohol dependency within 6 months. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (cf. 4.2.1). Current participation in another trial, or participation in a trial within a period of one month. Known hypersensitivity to any component of the formulation. Has no contra-indication to a placebo run-in period (e.g., recent stroke or MI). Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinik des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.385_U05.1492.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.385_literature.pdf
Description
Related Info

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

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