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Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.
In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.
In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH14755 | Experimental | PO, Once Daily, 16 weeks |
|
| Metformin | Active Comparator | PO, Once Daily, 16 weeks |
|
| Rosuvastatin | Active Comparator | PO, Once Daily, 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH14755 | Drug | 20/1500mg, QD |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol | Change from baseline at 16 weeks | |
| Change in HbA1c | Change from baseline at 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakcheol Jang, M.D., Ph.D. | Department of Internal Medicine, SNU Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Universitiy Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013449 |
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| Drug |
1500mg, QD |
|
| Rosuvastatin | Drug | 20mg, QD |
|
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| Sulfonamides |
| D000577 | Amides |
| 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 |