Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

This study is not yet open for participant recruitment.

Verified by Boehringer Ingelheim Pharmaceuticals, January 2010

First Received: May 18, 2009 Last Updated: January 13, 2010 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00904371

Purpose

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks. Further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.

Condition
Hypertension Cardiovascular Diseases

Study Type:	Observational
Study Design:	Prospective
Official Title:	Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is treatment efficacy on reducing blood pressure and its ability to reduce cardiovascular risk. [ Time Frame: 6 months ]

Secondary Outcome Measures:

Evaluation of antihypertensive treatment pattern Determine number of patients (percentage) that achieve target blood pressure values according to the ESH/ESC values [ Time Frame: 6 months ]

Estimated Enrollment:	250
Study Start Date:	December 2009
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

general practitioners and cardiologists

Criteria

Inclusion Criteria:

diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
at least an additional cardiovascular risk factor

Exclusion Criteria:

hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market
pregnancy and lactation
diseases involving biliary obstruction
severe liver impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904371

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Locations

Slovenia
Boehringer Ingelheim Investigational Site 1
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 2
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 1
Celje, Slovenia
Boehringer Ingelheim Investigational Site 2
Celje, Slovenia
Boehringer Ingelheim Investigational Site 3
Celje, Slovenia
Boehringer Ingelheim Investigational Site
Litija, Slovenia
Boehringer Ingelheim Investigational Site 1
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 2
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 1
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 2
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 1
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 2
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 3
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site
Zrece, Slovenia
Boehringer Ingelheim Investigational Site 2
Novo Mesto, Slovenia
Boehringer Ingelheim Investigational Site 3
Novo Mesto, Slovenia
Boehringer Ingelheim Investigational Site 4
Novo Mesto, Slovenia
Boehringer Ingelheim Investigational Site 5
Novo Mesto, Slovenia
Boehringer Ingelheim Investigational Site 1
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site 2
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site
Topolsica, Slovenia
Boehringer Ingelheim Investigational Site 1
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 2
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 3
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site
Velenje, Slovenia
Boehringer Ingelheim Investigational Site 1
Novo Mesto, Slovenia

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	502.585
Study First Received:	May 18, 2009
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00904371 History of Changes
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Telmisartan
Pharmacologic Actions
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010