Clinical trial NCT00904371: 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
Official title: Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Cardiovascular Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with arterial hypertension with moderate to very high cardiovascular risk

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Change From Baseline in Framingham CVD Risk Assessment Score
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Change From Baseline in Framingham Stroke Risk Assessment Score
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Change From Baseline in Risk Assessment According to ESH/ESC Guidelines
timeFrame: Baseline to 3rd visit (4-10 months)
Secondary outcomes:
measure: Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC
timeFrame: 3rd visit (4-10 months)
measure: Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
timeFrame: 3rd visit (4-10 months)
measure: Change in Heart Rate From Baseline to Study End
timeFrame: Baseline to 3rd visit (4-10 months)
measure: Number of Patients With Adverse Events (AE)
timeFrame: 4-10 months
measure: Number of Participants Not Completing Study
timeFrame: 3rd visit (4-10 months)
Other outcomes:
Locations:
city: Brezice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 24
city: Brezice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 2
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 12
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 16
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 17
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 1
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 33
city: Golnik
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 18
city: Golnik
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 23
city: Golnik
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 29
city: Golnik
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 32
city: Jesenice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 15
city: Kranj
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 4
city: Litija
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 28
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 26
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 35
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 3
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 6
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 14
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 22
city: Murska Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 20
city: Murska Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 27
city: Murska Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 31
city: Novo mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 11
city: Novo mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 19
city: Novo mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 21
city: Novo mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 9
city: Sempeter
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 25
city: Sempeter
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 30
city: Sezana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 34
city: Slovenj Gradec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 10
city: Slovenj Gradec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 36
city: Topolsica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 13
city: Trbovlje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 5
city: Trbovlje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 8
city: Velenje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 7
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: