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Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).
Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety:
Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental |
| |
| Telmisartan + Hydrochlorothiazide | Experimental |
| |
| Losartan | Active Comparator |
| |
| Losartan + Hydrochlorothiazide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Losartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study | Baseline and week 24 | |
| Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval |
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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 |
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| Hydrochlorothiazide | Drug |
|
| Baseline, week 12 and 24 |
| Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP) | Baseline, week 12 and 24 |
| Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP | Baseline, week 12 and 24 |
| Changes from baseline in SBP/DBP of 24 hours mean ABPM | Baseline, week 12 and 24 |
| Comparison of SBP/DBP ABPM tracing profile | Week 12 and 24 |
| Smoothness index in comparison with baseline | Baseline, week 12 and 24 |
| Number of responders | Week 12 and 24 |
| Number of controlled responders | Week 12 and 24 |
| Number of patients who withdraw due to lack of efficacy | 24 weeks |
| Number of patients with adverse events | 24 weeks |
| Number of patients who withdraw due to adverse events | 24 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |