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The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.
In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telmisartan plus low-dose hydrochlorothiazide | Active Comparator | 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide |
|
| Amlodipine | Active Comparator | Amlodipine is continuously administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan plus hydrochlorothiazide | Drug | Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in office blood pressure | After 12 week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients | After 12 week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiro Fujita, MD, PhD | Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine | Tokyo | 113-8655 | Japan |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| 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 |
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| Amlodipine | Device |
|
| 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 |