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A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irbesartan low/Amlodipine low | Experimental | Irbesartan low & Amlodipine low, once daily for 8 weeks |
|
| Irbesartan low/Amlodipine high | Experimental | Irbesartan low & Amlodipine high, once daily for 8 weeks |
|
| Irbesartan high/Amlodipine low | Experimental | Irbesartan high & Amlodipine low, once daily for 8 weeks |
|
| Irbesartan high/Amlodipine high | Experimental | Irbesartan high & Amlodipine high, once daily for 8 weeks |
|
| Amlodipine low | Active Comparator | Amlodipine low, once daily for 8 weeks |
|
| Amlodipine high | Active Comparator | Amlodipine high, once daily for 8 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan/Amlodipine | Drug | QID |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in MSSBP between baseline and Week8. | The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8. | Baseline and Week8 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in MSSBP between baseline and Week4. | Baseline and Week4 | |
| The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8. | Baseline and Week4/8 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | 03722 | South Korea |
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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 |
|---|---|
| D000077405 | Irbesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Irbesartan low | Active Comparator | Irbesartan low, once daily for 8 weeks |
|
| Irbesartan high | Active Comparator | Irbesartan high, once daily for 8 weeks |
|
| The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8. |
| Baseline and Week4/8 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |