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A phase â…¢, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R5 | Active Comparator | Rosuvastatin 5mg |
|
| R10 | Active Comparator | Rosuvastatin 10mg |
|
| R20 | Active Comparator | Rosuvastatin 20mg |
|
| R5/E10 | Experimental | Rosuvastatin 5mg/Ezetimibe 10mg |
|
| R10/E10 | Experimental | Rosuvastatin 10mg/Ezetimibe 10mg |
|
| R20/E10 | Experimental | Rosuvastatin 20mg/Ezetimibe 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 8 week in LDL-Cholesterol | baseline and 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 4 and 8 week in Total Cholesterol | baseline to 4 and 8 week | |
| Percent change from baseline to 4 and 8 week in Triglyceride | baseline to 4 and 8 week | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-soo Kim, MD/PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29402522 | Derived | Hong SJ, Jeong HS, Ahn JC, Cha DH, Won KH, Kim W, Cho SK, Kim SY, Yoo BS, Sung KC, Rha SW, Shin JH, Han KR, Chung WS, Hyon MS, Lee HC, Bae JH, Rhee MY, Kwan J, Jeon DW, Yoo KD, Kim HS. A Phase III, Multicenter, Randomized, Double-blind, Active Comparator Clinical Trial to Compare the Efficacy and Safety of Combination Therapy With Ezetimibe and Rosuvastatin Versus Rosuvastatin Monotherapy in Patients With Hypercholesterolemia: I-ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) Randomized Controlled Trial. Clin Ther. 2018 Feb;40(2):226-241.e4. doi: 10.1016/j.clinthera.2017.12.018. |
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| Ezetimibe |
| Drug |
|
| Percent change from baseline to 4 and 8 week in HDL-Cholesterol |
| baseline to 4 and 8 week |
| Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol | baseline to 4 and 8 week |
| Percent change from baseline to 4 and 8 week in Apolipoprotein B | baseline to 4 and 8 week |
| Percent change from baseline to 4 and 8 week in Apolipoprotein A1 | baseline to 4 and 8 week |
| Percent change from baseline to 4 week in LDL-Cholesterol | baseline to 4 week |
| Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein) | baseline to 4 and 8 |
| The change of LDL-Cholesterol/HDL-Cholesterol ratio | baseline to 4 and 8 week |
| The change of Total Cholesterol/HDL-Cholesterol ratio | baseline to 4 and 8 week |
| The change of non-HDL-Cholesterol/HDL-Cholesterol ratio | baseline to 4 and 8 week |
| The change of Apolipoprotein B/Apolipoprotein A1 ratio | baseline to 4 and 8 week |
| The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline | baseline to 4 and 8 week |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
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