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The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:
A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin |
|
| Control group | Active Comparator | Dose escalation of moderate-intensity statin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin | Drug | Treatment group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular events and diabetic microvascular events for 48 months | major adverse cardiovascular events and diabetic microvascular events for 48 months | 48month from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients achieving Non-HDL-C less than 100mg/dL | proportion of patients achieving Non-HDL-C less than 100mg/dL | 48month from baseline |
| proportion of patients achieving LDL less than 70mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SIN-GON KIM | Contact | 8229205890 | k50367@korea.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| SIN-GON KIM | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39174014 | Derived | Kim NH, Lee J, Chon S, Yu JM, Jeong IK, Lim S, Kim WJ, Song K, Cho HC, Yu HM, Kim KA, Kim SS, Lee SH, Kim CH, Kwak SH, Lee YH, Chung CH, Lee S, Jin HY, Lee JH, Koh G, Kim SY, Kim J, Lee JH, Kim TN, Jeon HJ, Lee JH, Jeon JH, Yoo HJ, Kim HK, Park HK, Nam-Goong IS, Hong S, Ahn CW, Yu JH, Park JH, Park KG, Park CH, Joung KH, Ryu OH, Park KY, Hong EG, Cha BS, Won KC, Chung YS, Kim SG. Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE). Endocrinol Metab (Seoul). 2024 Oct;39(5):722-731. doi: 10.3803/EnM.2024.1995. Epub 2024 Aug 22. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dose escalation of moderate-intensity statin |
| Drug |
Control group |
|
proportion of patients achieving LDL less than 70mg/dL
| 48month from baseline |
| change in Non-HDL-C at 48month from baseline | change in Non-HDL-C at 48month from baseline | 48month from baseline |
| change in LDL at 48month from baseline | change in LDL at 48month from baseline | 48month from baseline |
| change in HDL-C at 48month from baseline | change in HDL-C at 48month from baseline | 48month from baseline |
| change in TG at 48month from baseline | change in TG at 48month from baseline | 48month from baseline |
| change in LDL-C/HDL-C ratio at 48month from baseline | change in LDL-C/HDL-C ratio at 48month from baseline | 48month from baseline |
| change in TC/HDL-C ratio at 48month from baseline | change in TC/HDL-C ratio at 48month from baseline | 48month from baseline |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D058607 |
| Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |