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 - Full Text View

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:	Observational Model: Cohort Time Perspective: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of antihypertensive treatment pattern; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Determine number of patients (percentage) that achieve target blood pressure values according to the ESH/ESC values. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	211
Study Start Date:	December 2009
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Patients with arterial hypertention

Eligibility

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

Study Population

patients with arterial hypertension with moderate to very high cardiovascular risk

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

Locations

Slovenia
Boehringer Ingelheim Investigational Site 1
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 2
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 3
Celje, Slovenia
Boehringer Ingelheim Investigational Site 4
Celje, Slovenia
Boehringer Ingelheim Investigational Site 5
Celje, Slovenia
Boehringer Ingelheim Investigational Site 6
Celje, Slovenia
Boehringer Ingelheim Investigational Site 7
Celje, Slovenia
Boehringer Ingelheim Investigational Site 8
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 9
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 10
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 11
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 12
Jesenice, Slovenia
Boehringer Ingelheim Investigational Site 13
Kranj, Slovenia
Boehringer Ingelheim Investigational Site 14
Litija, Slovenia
Boehringer Ingelheim Investigational Site 15
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 16
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 17
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 18
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 19
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 20
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 21
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 22
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 23
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 24
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 25
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 29
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 27
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 28
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 26
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 30
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 31
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 37
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 38
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 36
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 35
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 32
Sezana, Slovenia
Boehringer Ingelheim Investigational Site 34
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site 33
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site 39
Topolsica, Slovenia
Boehringer Ingelheim Investigational Site 40
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 41
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 42
Velenje, Slovenia
Boehringer Ingelheim Investigational Site 43
Zrece, Slovenia

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00904371 History of Changes
Other Study ID Numbers:	502.585
Study First Received:	May 18, 2009
Last Updated:	April 8, 2011
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:

Cardiovascular Diseases
Hypertension
Vascular Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012