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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with arterial hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan or Telmisartan and Hydrochlorthiazide | Drug | Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | From baseline to visit 3 (6 months) |
| Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | 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) | From baseline to visit 3 (6 months) |
| Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | 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) | From baseline to visit 3 (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) | 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 | Visit 3 (6 months from baseline) |
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Inclusion criteria:
Exclusion criteria:
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Patients with arterial hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Arad | Romania | ||||
| Boehringer Ingelheim Investigational Site 5 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Number of participants discontinuing study early for given reason | 3rd visit (6 months) |
| Number of Patients With Adverse Events (AE) | 6 months |
| Bacau |
| Romania |
| Boehringer Ingelheim Investigational Site 6 | Baia Mare | Romania |
| Boehringer Ingelheim Investigational Site 9 | Brasov | Romania |
| Boehringer Ingelheim Investigational Site 8 | Brăila | Romania |
| Boehringer Ingelheim Investigational Site 10 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 11 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 12 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 13 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 14 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 15 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 16 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 17 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 18 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 19 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 20 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 21 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 22 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 23 | Buzău | Romania |
| Boehringer Ingelheim Investigational Site 24 | Calarasi | Romania |
| Boehringer Ingelheim Investigational Site 4 | Campulung Muscel | 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 28 | Cluj-Napoca | Romania |
| Boehringer Ingelheim Investigational Site 29 | Constanța | Romania |
| Boehringer Ingelheim Investigational Site 31 | Craiova | Romania |
| Boehringer Ingelheim Investigational Site 2 | Curtea de Argeş | Romania |
| Boehringer Ingelheim Investigational Site 38 | Drobeta-Turnu Severin | Romania |
| Boehringer Ingelheim Investigational Site 32 | Galati | Romania |
| Boehringer Ingelheim Investigational Site 34 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 35 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 36 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 37 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 7 | Oradea | Romania |
| Boehringer Ingelheim Investigational Site 3 | Piteşti | Romania |
| Boehringer Ingelheim Investigational Site 40 | Ploieşti | Romania |
| Boehringer Ingelheim Investigational Site 41 | Ploieşti | Romania |
| Boehringer Ingelheim Investigational Site 49 | Râmnicu Vâlcea | Romania |
| Boehringer Ingelheim Investigational Site 25 | Reşiţa | Romania |
| Boehringer Ingelheim Investigational Site 33 | Slobozia | Romania |
| Boehringer Ingelheim Investigational Site 43 | Suceava | Romania |
| Boehringer Ingelheim Investigational Site 30 | Targoviste | Romania |
| Boehringer Ingelheim Investigational Site 39 | Târgu Mureş | Romania |
| Boehringer Ingelheim Investigational Site 44 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 45 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 46 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 47 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 48 | Tulcea | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data on age available for 294 patients | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Systolic Blood Pressure (mean) | Mean | Standard Deviation | mmHg |
| ||||||||||||||||||||||
| Diastolic Blood Pressure (mean) | Mean | Standard Deviation | mmHg |
| ||||||||||||||||||||||
| Heart Rate | Data on heart rate available for 281 patients | Mean | Standard Deviation | beats/minute |
| |||||||||||||||||||||
| Additional antihypertensive treatment at baseline | Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent. | Number | Percentage of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure From Baseline to Study End | Patients with data both at baseline and on 3rd visit | Posted | Mean | Standard Deviation | mmHg | From baseline to visit 3 (6 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Change in Diastolic Blood Pressure From Baseline to Study End | Patients with data both at baseline and on 3rd visit | Posted | Mean | Standard Deviation | mmHg | From baseline to visit 3 (6 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | 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) | Patients with data both at baseline and on 3rd visit | Posted | Number | Percentage of participants | From baseline to visit 3 (6 months) |
|
| |||||||||||||||||||||||||||
| Primary | Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | 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) | Patients with data both at baseline and on 3rd visit | Posted | Number | Percentage of participants | From baseline to visit 3 (6 months) |
|
| |||||||||||||||||||||||||||
| Primary | Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | 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) | Patients with data both at baseline and on 3rd visit | Posted | Number | Percentage of participants | From baseline to visit 3 (6 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) | 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 | Patients with data at 3rd visit | Posted | Number | Percentage of participants | Visit 3 (6 months from baseline) |
|
| |||||||||||||||||||||||||||
| Secondary | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Patients with data at 3rd visit | Posted | Number | Percentage of participants | 6 Months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change in Heart Rate From Baseline to Study End | Patients with data both at baseline and on 3rd visit | Posted | Mean | Standard Deviation | beats / minute | From baseline to visit 3 (6 months) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Not Completing Study | Number of participants discontinuing study early for given reason | Patients with data at 3rd visit | Posted | Number | Number of participants | 3rd visit (6 months) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events (AE) | Treated patients | Posted | Number | Number of participants | 6 months |
|
|
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | 1 | 295 | 0 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalized angioedema | General disorders | MedDRA Version 14.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Calcium Channel Blockers |
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| Beta Blockers |
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| Other |
|
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|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Diuretics |
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| Calcium Channel Blockers |
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| Beta Blockers |
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| Other |
|
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| Adverse Event |
|
| Lost to follow up |
|
|