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To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Drug | Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Blood Pressure < 140/90 mm Hg | % of high risk patients with Blood Pressure < 140/90 mm Hg | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Blood Pressure < 130/80 mm Hg | 12 weeks | |
| Absolute Blood Pressure Decrease | systolic blood pressure | baseline and 12 weeks |
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Inclusion criteria:
Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria
Exclusion criteria:
Contra-indications as in the Summary of Product Characteristics
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community sample
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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45 patients excluded for inclusion/exclusion criteria
April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Percentage of Patients With Blood Pressure < 140/90 mm Hg | % of high risk patients with Blood Pressure < 140/90 mm Hg | Intention-to-Treat (ITT) | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
|
12 weeks
solicited reporting
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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 | Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 13.1 | 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 |
|---|---|
| C436283 | telmisartan, hydrochlorothiazide drug combination |
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| BP Response Rate (Drop of Systolic BP of 10mmHg or More) | BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ) | 12 weeks |
| Treatment Patterns | Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications). | 12 weeks |
| Change in Concomitant Antihypertensive Drugs Given at Study Entry | Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not. | baseline and 12 weeks |
| Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg | 12 weeks |
| Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 | Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients | 12 weeks |
| years |
|
| Sex/Gender, Customized | Number | percentage of participants |
|
| Systolic and diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
|
| Secondary | Percentage of Patients With Blood Pressure < 130/80 mm Hg | Intention to Treat (ITT) | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
|
|
| Secondary | Absolute Blood Pressure Decrease | systolic blood pressure | Intention to treat (ITT) | Posted | Mean | 95% Confidence Interval | mm Hg | baseline and 12 weeks |
|
|
|
| Secondary | BP Response Rate (Drop of Systolic BP of 10mmHg or More) | BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ) | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of patients | 12 weeks |
|
|
|
| Secondary | Treatment Patterns | Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications). | ITT Population | Posted | Number | Percentage of patients | 12 weeks |
|
|
|
| Secondary | Change in Concomitant Antihypertensive Drugs Given at Study Entry | Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not. | Intention to treat (ITT) | Posted | Number | 95% Confidence Interval | percentage of patients | baseline and 12 weeks |
|
|
|
| Secondary | Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg | Intention to treat (ITT) | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks |
|
|
|
| Secondary | Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 | Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients | all investigators participating in the trial | Posted | Number | 95% Confidence Interval | percentage of prescribers | 12 weeks |
|
|
|
| 3 |
| 2,771 |
| 0 |
| 2,771 |
| Alcohol detoxification | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| cerebral hemorrhage, fatal | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Other - 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.
| Telmisartan 80/12,5mg |
|
| Telmisartan 80/25mg |
|