Clinical trial NCT01108809: Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients
Official title: Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 295
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

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 risk scores. The study will also 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 one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

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, as prescribed in the SPC
* pregnancy and lactation
* diseases involving biliary obstruction
* severe liver impairment
* severe hypertension
* malignant hypertension
* secondary hypertension
* patients age under 18 years

Primary outcomes:
measure: Change in Systolic Blood Pressure From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
measure: Change in Diastolic Blood Pressure From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
measure: Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
measure: Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
measure: Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
Secondary outcomes:
measure: Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)
timeFrame: Visit 3 (6 months from baseline)
measure: Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
timeFrame: 6 Months
measure: Change in Heart Rate From Baseline to Study End
timeFrame: From baseline to visit 3 (6 months)
measure: Number of Participants Not Completing Study
timeFrame: 3rd visit (6 months)
measure: Number of Patients With Adverse Events (AE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Arad
country: Romania
facility: Boehringer Ingelheim Investigational Site 1
city: Bacau
country: Romania
facility: Boehringer Ingelheim Investigational Site 5
city: Baia Mare
country: Romania
facility: Boehringer Ingelheim Investigational Site 6
city: Braila
country: Romania
facility: Boehringer Ingelheim Investigational Site 8
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 9
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 10
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 11
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 12
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 13
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 14
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 15
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 16
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 17
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 18
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 19
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 20
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 21
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 22
city: Buzau
country: Romania
facility: Boehringer Ingelheim Investigational Site 23
city: Calarasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 24
city: Campulung
country: Romania
facility: Boehringer Ingelheim Investigational Site 4
city: Carei
country: Romania
facility: Boehringer Ingelheim Investigational Site 42
city: Cluj-Napoca
country: Romania
facility: Boehringer Ingelheim Investigational Site 26
city: Cluj-Napoca
country: Romania
facility: Boehringer Ingelheim Investigational Site 27
city: Cluj-Napoca
country: Romania
facility: Boehringer Ingelheim Investigational Site 28
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 29
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational Site 31
city: Curtea de Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 2
city: Drobeta-Turnu Severin
country: Romania
facility: Boehringer Ingelheim Investigational Site 38
city: Galati
country: Romania
facility: Boehringer Ingelheim Investigational Site 32
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 34
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 35
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 36
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 37
city: Oradea
country: Romania
facility: Boehringer Ingelheim Investigational Site 7
city: Pitesti
country: Romania
facility: Boehringer Ingelheim Investigational Site 3
city: Ploiesti
country: Romania
facility: Boehringer Ingelheim Investigational Site 40
city: Ploiesti
country: Romania
facility: Boehringer Ingelheim Investigational Site 41
city: Ramnicu-Valcea
country: Romania
facility: Boehringer Ingelheim Investigational Site 49
city: Resita
country: Romania
facility: Boehringer Ingelheim Investigational Site 25
city: Slobozia
country: Romania
facility: Boehringer Ingelheim Investigational Site 33
city: Suceava
country: Romania
facility: Boehringer Ingelheim Investigational Site 43
city: Targoviste
country: Romania
facility: Boehringer Ingelheim Investigational Site 30
city: Targu-Mures
country: Romania
facility: Boehringer Ingelheim Investigational Site 39
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 44
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 45
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 46
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 47
city: Tulcea
country: Romania
facility: Boehringer Ingelheim Investigational Site 48
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: