NCT00274144

CompletedPhase 4

Inflammation and Coronary Artery Disease: Role of AT1-Recept...

Boehringer Ingelheim Source

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Other study identifiers

Sponsor study identifier

502.385

Study Type

interventional

Reported enrollment (type unavailable)

42

Locations

1 country

Sites

1

Timeline

Study Start

December 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2004

Actual (reported)

Study Completion

May 2004

Date type not reported

This date has not been verified as actual or estimated.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 42 participants
Study completion date: May 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2001
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2004
Actual (reported)
Study Completion
May 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 9, 2006
Actual (reported)
First Posted
January 10, 2006
Actual (reported)

Last Updated: November 1, 2013
Status Verified: October 2013
Last Update Submitted: October 31, 2013

Conditions

Hypertension Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (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.

Interventions

telmisartan 40 mgDrug

placebo 40 mgDrug

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Boehringer Ingelheim
Industrylead

Study Sites (1)

Universitätsklinik des Saarlandes

Homburg/Saar, 66421, Germany

MeSH Terms

Conditions

HypertensionCoronary Artery Disease

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

Boehringer Ingelheim Study Coordinator
B.I. Pharma GmbH & Co. KG
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

December 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2004

Actual (reported)

NCT02200640

A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)

Phase 4Completed

NCT02242318

Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring

Phase 4Completed

NCT00274612

Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM

Phase 4Completed

NCT00274599

PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Phase 4Completed

NCT02242812

Telmisartan Effectiveness on Left Ventricular Mass Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension

Phase 4Terminated

NCT00946829

Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise

Completed

\> 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.

You may not qualify if:

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.
+12 more criteria

Contact the study team to confirm eligibility.

Hydrocarbons, Cyclic

Hydrocarbons

Organic Chemicals

Benzimidazoles

Heterocyclic Compounds, 2-Ring

Heterocyclic Compounds, Fused-Ring

Heterocyclic Compounds

Study Completion

May 2004

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

November 1, 2013

Record last verified: 2013-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00274144
Data provider: ClinicalTrials.gov
Source updated: 2013-11-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:38 UTC

Locations

DE(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations