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The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.
STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.
HYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).
STUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.
Subjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin IR Tablet | Active Comparator | Rosuvastatin Immediate-Release Tablet (IRT) 10mg |
|
| SUVARO®OD Tablet | Experimental | Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin Immediate-Release Tablet (IRT) 10mg | Drug | Rosuvastatin Immediate-Release Tablet (IRT) 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C level from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 | |
| Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Sun Kim | Contact | +82-2-2228-8457 | kjs1218@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Sun Kim | Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity, | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11524058 | Background | Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001 Sep 1;88(5):504-8. doi: 10.1016/s0002-9149(01)01727-1. | |
| 30483816 | Background | Zhang L, Zhang S, Yu Y, Jiang H, Ge J. Efficacy and safety of rosuvastatin vs. atorvastatin in lowering LDL cholesterol : A meta-analysis of trials with East Asian populations. Herz. 2020 Sep;45(6):594-602. doi: 10.1007/s00059-018-4767-2. Epub 2018 Nov 27. |
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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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| Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg | Drug | Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg |
|
| Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 |
| 20195400 | Background | Park JS, Kim YJ, Choi JY, Kim YN, Hong TJ, Kim DS, Kim KY, Jeong MH, Chae JK, Oh SK, Seong IW. Comparative study of low doses of rosuvastatin and atorvastatin on lipid and glycemic control in patients with metabolic syndrome and hypercholesterolemia. Korean J Intern Med. 2010 Mar;25(1):27-35. doi: 10.3904/kjim.2010.25.1.27. Epub 2010 Feb 26. |