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Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arterial hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micardis | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Change of Systolic Blood Pressure) | Change from baseline in 24h systolic blood pressure (BP) at week 8 | baseline to 8 weeks |
| Efficacy (Change of Diastolic Blood Pressure) | Change from baseline in 24h diastolic blood pressure (BP) at week 8 | baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tolerability Scale | Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10 | 8 weeks |
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Inclusion criteria:
Exclusion criteria:
None (according to investigator)
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hypertensive patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan, Hydrochlorothiazide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan, Hydrochlorothiazide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Efficacy (Change of Systolic Blood Pressure) | Change from baseline in 24h systolic blood pressure (BP) at week 8 | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | mm Hg | baseline to 8 weeks |
|
|
56 Days
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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, Hydrochlorothiazide |
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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 |
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| Year |
|
| Gender | 20 subjects did not indicate any specific gender | Number | participants |
|
| Baseline Diastolic Blood Pressure (DBP) values (ABPM) | Mean | Standard Deviation | mm Hg |
|
| Baseline Systolic Blood Pressure (SBP) values (ABPM) | Mean | Standard Deviation | mm Hg |
|
|
| Primary | Efficacy (Change of Diastolic Blood Pressure) | Change from baseline in 24h diastolic blood pressure (BP) at week 8 | Posted | Mean | Standard Deviation | mm Hg | baseline to 8 weeks |
|
|
|
| Secondary | Overall Tolerability Scale | Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 701 |
| 0 |
| 701 |
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.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |