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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 risks. Further on, the study will 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 hypertention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline to 3rd visit (4-10 months) | |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline to 3rd visit (4-10 months) | |
| Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event) | A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. | Baseline to 3rd visit (4-10 months) |
| Change From Baseline in Framingham CVD Risk Assessment Score | 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). | Baseline to 3rd visit (4-10 months) |
| Change From Baseline in Framingham Stroke Risk Assessment Score | The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more). | Baseline to 3rd visit (4-10 months) |
| Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | ESH is the European society of hypertension, and ESC is the European society of cardiology. | Baseline to 3rd visit (4-10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to 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 | 3rd visit (4-10 months) |
| Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) |
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Inclusion criteria:
Exclusion criteria:
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patients with arterial hypertension with moderate to very high cardiovascular risk
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 24 | Brežice | Slovenia | ||||
| Boehringer Ingelheim Investigational Site 2 |
Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micardis® 80mg; MicardisPlus® 80/12.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent. |
| 3rd visit (4-10 months) |
| Change in Heart Rate From Baseline to Study End | Baseline to 3rd visit (4-10 months) |
| Number of Patients With Adverse Events (AE) | 4-10 months |
| Number of Participants Not Completing Study | Number of participants discontinuing study early for given reason | 3rd visit (4-10 months) |
| Brežice |
| Slovenia |
| Boehringer Ingelheim Investigational Site 12 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 16 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 17 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 1 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 33 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 18 | Golnik | Slovenia |
| Boehringer Ingelheim Investigational Site 23 | Golnik | Slovenia |
| Boehringer Ingelheim Investigational Site 29 | Golnik | Slovenia |
| Boehringer Ingelheim Investigational Site 32 | Golnik | Slovenia |
| Boehringer Ingelheim Investigational Site 15 | Jesenice | Slovenia |
| Boehringer Ingelheim Investigational Site 4 | Kranj | Slovenia |
| Boehringer Ingelheim Investigational Site 28 | Litija | Slovenia |
| Boehringer Ingelheim Investigational Site 26 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 35 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 3 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 6 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 14 | Maribor | Slovenia |
| Boehringer Ingelheim Investigational Site 22 | Maribor | Slovenia |
| Boehringer Ingelheim Investigational Site 20 | Murska Sobota | Slovenia |
| Boehringer Ingelheim Investigational Site 27 | Murska Sobota | Slovenia |
| Boehringer Ingelheim Investigational Site 31 | Murska Sobota | Slovenia |
| Boehringer Ingelheim Investigational Site 11 | Novo Mesto | Slovenia |
| Boehringer Ingelheim Investigational Site 19 | Novo Mesto | Slovenia |
| Boehringer Ingelheim Investigational Site 21 | Novo Mesto | Slovenia |
| Boehringer Ingelheim Investigational Site 9 | Novo Mesto | Slovenia |
| Boehringer Ingelheim Investigational Site 25 | Sempeter | Slovenia |
| Boehringer Ingelheim Investigational Site 30 | Sempeter | Slovenia |
| Boehringer Ingelheim Investigational Site 34 | Sežana | Slovenia |
| Boehringer Ingelheim Investigational Site 10 | Slovenj Gradec | Slovenia |
| Boehringer Ingelheim Investigational Site 36 | Slovenj Gradec | Slovenia |
| Boehringer Ingelheim Investigational Site 13 | Topolšica | Slovenia |
| Boehringer Ingelheim Investigational Site 5 | Trbovlje | Slovenia |
| Boehringer Ingelheim Investigational Site 8 | Trbovlje | Slovenia |
| Boehringer Ingelheim Investigational Site 7 | Velenje | Slovenia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micardis® 80mg; MicardisPlus® 80/12.5 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Gender | There were only 203 patients with non-missing gender | Number | Participants |
| ||||||||||||||||||||||
| 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 From Baseline in Systolic Blood Pressure (SBP) | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Mean | Standard Deviation | mm Hg | Baseline to 3rd visit (4-10 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Diastolic Blood Pressure (DBP) | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Mean | Standard Deviation | mm Hg | Baseline to 3rd visit (4-10 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event) | A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3rd visit (4-10 months) |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Framingham CVD Risk Assessment Score | 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). | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3rd visit (4-10 months) |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Framingham Stroke Risk Assessment Score | The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more). | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3rd visit (4-10 months) |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | ESH is the European society of hypertension, and ESC is the European society of cardiology. | Patients with data both at baseline and on 3rd visit (4-10 months) | Posted | Number | Participants moved into category | Baseline to 3rd visit (4-10 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to 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 (4-10 months) | Posted | Number | Percentage of participants | 3rd visit (4-10 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent. | Patients with data at 3rd visit (4-10 months) | Posted | Number | Percentage of participants | 3rd visit (4-10 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Heart Rate From Baseline to Study End | Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status | Posted | Mean | Standard Deviation | Beats per minute | Baseline to 3rd visit (4-10 months) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events (AE) | Treated patients | Posted | Number | Participants | 4-10 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Not Completing Study | Number of participants discontinuing study early for given reason | Patients with data at 3rd visit (4-10 months) | Posted | Number | Participants | 3rd visit (4-10 months) |
|
|
|
6 months
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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® 80mg MicardisPlus® 80/12.5 mg | 2 | 211 | 0 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Lip oedema | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| Calcium Channel Blockers |
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| Beta Blockers |
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| Other |
|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Average risk |
| |||||
| Low added risk |
| |||||
| Moderate added risk |
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| Very high added risk |
|
| Title | Denominators | Categories |
|---|
| Achieved target BP values |
| |||||
| Not achieved target BP values |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| ACE inhibitors |
| |||||
| Diuretics |
| |||||
| Calcium Channel Blockers |
| |||||
| Beta Blockers |
| |||||
| Other |
|
|
| Title | Measurements |
|---|---|
|
| Adverse Event |
| |||||
| Lost to follow up |
| |||||
| Discontinued at target BP |
| |||||
| Continued with Tritace |
|