NCT00274144

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Dec 2001

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

HypertensionCoronary 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
  • \> 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.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik des Saarlandes

Homburg/Saar, 66421, Germany

Location

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, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 1, 2001

Primary Completion

March 1, 2004

Study Completion

May 1, 2004

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)