Dyslipidemia Clinical Trial
Official title:
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
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.
| Status | Recruiting |
| Enrollment | 112 |
| Est. completion date | August 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: 1. Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months 2. Written informed consent to participate in the trial Exclusion Criteria: 1. History of previous hypersensitivity reaction to other statins, including rosuvastatin 2. patients with acute arterial disease within 3 months 3. Uncontrolled Hypertensive Patients defined as SBP =180 mm Hg and DBP =110 mm Hg, respectively 4. Uncontrolled diabetes mellitus (HbA1c > 9%) 5. Uncontrolled hypothyroidism defined as TSH >1.5 within the last 6 months 6. Taking other lipid lowering agent except statins 7. History of statin-induced myopathy, rhabdomyolysis 8. Patients with severe hepatic or renal dysfunction 9. BMI (body mass index) > 40 kg/m2 10. history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity, | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in LDL-C level from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 | ||
| Secondary | Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 | ||
| Secondary | Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 | ||
| Secondary | Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week | Week 0, 8, 16 |
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