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The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.
This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candemore tablet | Experimental | Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks |
|
| Cozzar tablet | Active Comparator | Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candemore tablet | Drug | Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks. dosage is depends on the sitting blood pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks | baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks | baseline, 8 weeks | |
| change from baseline average sitting SBP(systolic blood pressure)at 8 weeks | baseline, 8 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| rate of adverse event | up to 16 weeks | |
| medication history | up to 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myungho Jeong, phD | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam national university hospital | Daejeon | 301-721 | South Korea | |||
| The catholic university of Korea, Daejeon st. Mary's Hospital |
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| Cozzar tablet | Drug | Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure |
|
| change from baseline average sitting SBP(systolic blood pressure)at 16 weeks |
| baseline, 16 weeks |
| ratio of normalize from baseline blood pressure at 16 weeks | normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg | baseline, 16 weeks |
| response ratio from baseline blood pressure at 16 weeks | response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg | baseline, 16 weeks |
| change from baseline LVEF(left ventricular ejection fraction at 16 weeks | baseline, 16 weeks |
| change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks | baseline, 16 weeks |
| change from baseline LV(left ventricular) mass at 16 weeks | baseline, 16 weeks |
| change from baseline PWV(pulse wave velocity) mass at 16 weeks | baseline, 16 weeks |
| Daejeon |
| 301-723 |
| South Korea |
| Konyang university hospital | Daejeon | 302-718 | South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Chunnam National University Hospital | Gwangju | 501-757 | South Korea |
| Kwangju Christian Hospital | Gwangju | 503-715 | South Korea |
| Presbyterian Medical Center | Jeonju | 560-750 | South Korea |
| Chunbuk National University Hospital | Jeonju | 561-712 | South Korea |
| ST.Carollo hospital | Suncheon | 540-719 | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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