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The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amosartan® tab | Experimental | Amlodipine 5mg /Losartan 100mg |
|
| Cozaar® plus pro tab | Active Comparator | Losartan 100mg/ HCTZ 12.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amosartan® tab | Drug | comparison of different combination of anti-hypertension drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MSDBP | Baseline, week 4 | |
| Change from baseline Mean Seated Systolic Blood Pressure (MSSBP) | Baseline, Week 4 and 8 | |
| Blood pressure responder rate |
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Inclusion Criteria:
Exclusion Criteria:
Patients with too high Blood pressure
•≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
Secondary hypertension or suspected to be
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| Name | Affiliation | Role |
|---|---|---|
| Taehoon Ahn, Ph.D. | Gachon University Gil Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D019808 | Losartan |
| D011392 | Proline |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Cozaar® plus pro tab | Drug | comparison of different combination of anti-hypertension drug |
|
|
Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg and MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline. |
| Baseline, Week 4 and 8 |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |