NCT06153433

Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Rosuvastatin Immediate-Release Tablet (IRT) 10mg	Rosuvastatin Immediate-Release Tablet (IRT) 10mg
DRUG	Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg	Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-07-01
• Completion: 2024-08-01
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: South Korea