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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
Seoul, South Korea
RECRUITINGChange in LDL-C level from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week
Time frame: Week 0, 8, 16
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