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To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of telmisartan | Experimental | 4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan |
|
| High dose of telmisartan | Experimental | After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of telmisartan | Drug |
| ||
| High dose of telmisartan |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Blood pressure values were obtained 24 hours after the last dose (through values) at the office | Baseline, up to 12 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of treatment response for SBP/DBP (in %) | Response categories:
| Baseline, up to 12 weeks after start of treatment |
| Changes from baseline in blood pressure values |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Drug |
|
| Placebo | Drug |
|
Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup
| Baseline, up to 12 weeks after start of treatment |
| Number of patients with adverse events | Up to 16 weeks |
| Number of patients with clinically significant changes in laboratory values | Up to 16 weeks |
| Number of patients with clinically significant changes in ECG | Up to 16 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |