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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_004 | Other Identifier | Merck Registration Number |
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This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with hypertension treated with amlodipine/losartan(Cozaar XQ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine/losartan | Drug | amlodipine/losartan (COZAAR XQ) prescribed according to the current local label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any adverse experience | Up to 14 days after last treatment | |
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator | At 8 weeks after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator | At 24 weeks after first treatment |
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Inclusion criteria:
Exclusion criteria:
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Participants with essential hypertension not adequately controlled with amlodipine or losartan monotherapy; initial therapy for participants with stage 2 hypertension
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000710253 | amlodipine-losartan drug combination |
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