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The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irbesartan/Atorvastatin A | Experimental |
| |
| Irbesartan | Active Comparator |
| |
| Atorvastatin A | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| Irbesartan/Atorvastatin B | Experimental |
| |
| Atorvastatin B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan/Atorvastatin A | Drug | once daily, P.O. 8week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 8 week in LDL-Cholesterol | baseline and 8 week | |
| Change from baseline to 8 week in Blood Pressure. | baseline and 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline. | week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byeong Hee Oh, M.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 16 institutions including Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27742464 | Derived | Kim SH, Jo SH, Lee SC, Lee SY, Yoon MH, Lee HL, Lee NH, Ha JW, Lee NH, Kim DW, Han GR, Hyon MS, Cho DG, Park CG, Kim YD, Ryu GH, Kim CH, Kim KS, Chung MH, Chae SC, Seung KB, Oh BH. Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study. Clin Ther. 2016 Oct;38(10):2171-2184. doi: 10.1016/j.clinthera.2016.09.005. Epub 2016 Oct 12. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Irbesartan | Drug | once daily, P.O. 8week |
|
| Atorvastatin A | Drug | once daily, P.O. 8week |
|
| Placebo | Drug | once daily, P.O. 8week |
|
| Irbesartan/Atorvastatin B | Drug | once daily, P.O. 8week |
|
|
| Atorvastatin B | Drug | once daily, P.O. 8week |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |