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The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.
Study conduct according to the standard operating procedure
Data quality control
Monitoring
Measures taken to cope with adverse events and reporting procedure
Data Management
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 20mg, monotherapy | Active Comparator | Atorvastatin 20mg/day PO for 12weeks |
|
| Atorvastatin 10mg, Fenofibric acid 135mg | Experimental | Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10mg, fenofibric acid 135mg | Drug | Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of non-HDL cholesterol | -change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100 | at screening and after 12 weeks |
| levelresponse rate of non-HDL cholesterol level < 130mg/dL | -Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100 | at screening and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes of TC,HDL-C,LDL-C,TG,Apo B/A1 | at screening and after 12 weeks | |
| Changes of Glucose, HbA1c, HOMA-IR level | HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5 |
| Measure | Description | Time Frame |
|---|---|---|
| changes of BUN/Cr level | at screening and after 12 weeks | |
| Changes of Homocysteine level | at screening and after 12 weeks |
Inclusion Criteria:
patients of the age of 20years or older
patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening
patients who meet the following criteria
patients who consent for the consent before enrolling the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hak Lee, PhD | Severance Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19195513 | Result | Goldberg AC, Bays HE, Ballantyne CM, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. Am J Cardiol. 2009 Feb 15;103(4):515-22. doi: 10.1016/j.amjcard.2008.10.025. Epub 2008 Dec 26. | |
| 20934572 | Result |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C006012 | fenofibric acid |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| atorvastatin 20mg | Drug | Atorvastatin 20mg/day PO for 12weeks |
|
|
| at screening and after 12 weeks |
| Changes of hs-CRP, adiponectin, resistin level | at screening and after 12 weeks |
| Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045. |
| 19081418 | Result | Mohiuddin SM, Pepine CJ, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J. 2009 Jan;157(1):195-203. doi: 10.1016/j.ahj.2008.08.027. Epub 2008 Nov 20. |
| 15247520 | Result | Kishikawa R, M-Horiuti T, Togawa A, Kondoh Y, Janzy PD, Goldblum RM, Kotoh E, Shimoda T, Shoji S, Nishima S, Brooks EG. [Juniper pollen monitoring by Burkard sampler in Galveston, Texas, USA and Japanese cedar pollen counting in Fukuoka, Japan -- introduction of Pan American Aerobiology Association protocol counting technique]. Arerugi. 2004 Jun;53(6):582-8. Japanese. |
| 18996523 | Result | Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5. |
| 22592524 | Result | Filippatos TD. A review of time courses and predictors of lipid changes with fenofibric acid-statin combination. Cardiovasc Drugs Ther. 2012 Jun;26(3):245-55. doi: 10.1007/s10557-012-6394-0. |
| 17520105 | Result | Chatley P, Badyal DK, Calton R, Khosla PP. Combination therapy of low-dose atorvastatin and fenofibrate in mixed hyperlipidemia. Methods Find Exp Clin Pharmacol. 2007 Apr;29(3):217-21. doi: 10.1358/mf.2007.29.3.1075363. |
| 20110022 | Result | Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007. |
| 18650989 | Result | Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Iyer S, Shah KJ, Goyal RK. Beneficial effects of the addition of fenofibrate to statin therapy in patients with acute coronary syndrome after percutaneous coronary interventions. Exp Clin Cardiol. 2007 Summer;12(2):91-6. |
| 20816118 | Result | Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. Am J Cardiol. 2010 Sep 15;106(6):787-92. doi: 10.1016/j.amjcard.2010.05.005. Epub 2010 Aug 2. |
| D006951 | Hyperlipoproteinemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |