Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients
- Registration Number
- NCT01108809
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with arterial hypertension Telmisartan or Telmisartan and Hydrochlorthiazide -
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure From Baseline to Study End From baseline to visit 3 (6 months) Change in Diastolic Blood Pressure From Baseline to Study End From baseline to visit 3 (6 months) Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End From baseline to visit 3 (6 months) A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End From baseline to visit 3 (6 months) 10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End From baseline to visit 3 (6 months) ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
- Secondary Outcome Measures
Name Time Method Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) Visit 3 (6 months from baseline) ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) 6 Months Change in Heart Rate From Baseline to Study End From baseline to visit 3 (6 months) Number of Participants Not Completing Study 3rd visit (6 months) Number of participants discontinuing study early for given reason
Number of Patients With Adverse Events (AE) 6 months
Trial Locations
- Locations (49)
Boehringer Ingelheim Investigational Site 6
🇷🇴Baia Mare, Romania
Boehringer Ingelheim Investigational Site 10
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 8
🇷🇴Braila, Romania
Boehringer Ingelheim Investigational Site 11
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 18
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 13
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 16
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 22
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 28
🇷🇴Cluj-Napoca, Romania
Boehringer Ingelheim Investigational Site 23
🇷🇴Buzau, Romania
Boehringer Ingelheim Investigational Site 4
🇷🇴Campulung, Romania
Boehringer Ingelheim Investigational Site 42
🇷🇴Carei, Romania
Boehringer Ingelheim Investigational Site 26
🇷🇴Cluj-Napoca, Romania
Boehringer Ingelheim Investigational Site 27
🇷🇴Cluj-Napoca, Romania
Boehringer Ingelheim Investigational Site 31
🇷🇴Craiova, Romania
Boehringer Ingelheim Investigational Site 32
🇷🇴Galati, Romania
Boehringer Ingelheim Investigational Site 35
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 37
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 7
🇷🇴Oradea, Romania
Boehringer Ingelheim Investigational Site 3
🇷🇴Pitesti, Romania
Boehringer Ingelheim Investigational Site 41
🇷🇴Ploiesti, Romania
Boehringer Ingelheim Investigational Site 49
🇷🇴Ramnicu-Valcea, Romania
Boehringer Ingelheim Investigational Site 25
🇷🇴Resita, Romania
Boehringer Ingelheim Investigational Site 33
🇷🇴Slobozia, Romania
Boehringer Ingelheim Investigational Site 43
🇷🇴Suceava, Romania
Boehringer Ingelheim Investigational Site 44
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 12
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 19
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 36
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 40
🇷🇴Ploiesti, Romania
Boehringer Ingelheim Investigational Site 45
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 1
🇷🇴Arad, Romania
Boehringer Ingelheim Investigational Site 5
🇷🇴Bacau, Romania
Boehringer Ingelheim Investigational Site 9
🇷🇴Brasov, Romania
Boehringer Ingelheim Investigational Site 15
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 14
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 17
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 20
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 21
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 24
🇷🇴Calarasi, Romania
Boehringer Ingelheim Investigational Site 29
🇷🇴Constanta, Romania
Boehringer Ingelheim Investigational Site 2
🇷🇴Curtea de Arges, Romania
Boehringer Ingelheim Investigational Site 34
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 38
🇷🇴Drobeta-Turnu Severin, Romania
Boehringer Ingelheim Investigational Site 46
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 48
🇷🇴Tulcea, Romania
Boehringer Ingelheim Investigational Site 30
🇷🇴Targoviste, Romania
Boehringer Ingelheim Investigational Site 39
🇷🇴Targu-Mures, Romania
Boehringer Ingelheim Investigational Site 47
🇷🇴Timisoara, Romania