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A Multi-center, Randomized, Double-blind, Parallel Phase â…£ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| statin / fenofibrate | Experimental | stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O |
|
| statin / fenofibrate placebo | Placebo Comparator | stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O |
| Measure | Description | Time Frame |
|---|---|---|
| rate of change for Triglyceride based on baseline | 8week |
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Inclusion Criteria:
both male and female who are over 19-year-old
200mg/dl≤TG<500mg/dl
Desired value of LDL-c
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinmin Lee | Contact | 82-2-2204-7001 | jmlee@daewonpharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Hwaseong-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34518033 | Derived | Park MS, Youn JC, Kim EJ, Han KH, Lee SH, Kim SH, Kim BJ, Kwon SU, Ryu KH. Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study. Clin Ther. 2021 Oct;43(10):1735-1747. doi: 10.1016/j.clinthera.2021.08.005. Epub 2021 Sep 10. |
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|
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| 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 |
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