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The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug | telmisartan 80 mg once daily |
| |
| Hydrochlorothiazide |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg | Up to one year | |
| Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy | Up to one year | |
| Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy | Up to one year | |
| Mean sitting diastolic blood pressure during each visit | At months 3, 6, 9, 12 | |
| Mean sitting systolic blood pressure during each visit | At months 3, 6, 9, 12 | |
| Number of patient with adverse events | Up to one year | |
| Changes from baseline in heart rate | Baseline and at months 3, 6, 9, 12 | |
| Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram) | Baseline and 12 months | |
| Number of patients with abnormal changes in laboratory parameters | Baseline and 12 months | |
| Number of patients with abnormal findings in physical examination | Baseline and at 12 month |
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Inclusion Criteria:
Patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. All patients must give a separate written informed consent for participation in the open-label follow-up.
Exclusion Criteria:
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| Drug |
12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
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