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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06153433
Study type Interventional
Source Yonsei University
Contact Jung-Sun Kim
Phone +82-2-2228-8457
Email kjs1218@yuhs.ac
Status Recruiting
Phase Phase 4
Start date November 6, 2023
Completion date August 2024

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