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Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with non-secondary, essential hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of changes in heart rate | Baseline, up to 8 weeks after start of treatment | |
| Assessment for patients with changes in laboratory values | Baseline, up to 8 weeks after start of treatment | |
| Number of patients with adverse events | Up to 8 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean systolic and diastolic blood pressure values | Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours | Baseline, up to 8 weeks after start of treatment |
| Changes in mean systolic and diastolic blood pressure values |
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Inclusion Criteria:
- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)
Exclusion Criteria:
- corresponding to the contraindications listed in the summary of product characteristics of the drug
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Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists
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| 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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Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer |
| Baseline, up to 8 weeks after start of treatment |
| Evaluation of treatment compliance as percentage of tablets planned | (number of tablets taken / total number of days) x 100 | Up to 8 weeks after start of treatment |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |