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

Phase 4

Recruiting

• Conditions: Dyslipidemia
• Interventions: Drug: Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg; Drug: Rosuvastatin Immediate-Release Tablet (IRT) 10mg

• Registration Number: NCT06153433
• Lead Sponsor: Yonsei University

Brief 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

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-06
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SUVARO®OD Tablet	Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg	Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Rosuvastatin IR Tablet	Rosuvastatin Immediate-Release Tablet (IRT) 10mg	Rosuvastatin Immediate-Release Tablet (IRT) 10mg

Primary Outcome Measures

Name	Time	Method
Change in LDL-C level from Baseline after treatment of each formulation for 8 week	Week 0, 8, 16

Secondary Outcome Measures

Name	Time	Method
Change in High-density lipoprotein (HDL) from Baseline after treatment of each formulation for 8 week	Week 0, 8, 16
Change in Triglycerides (TG) from Baseline after treatment of each formulation for 8 week	Week 0, 8, 16
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week	Week 0, 8, 16

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,; 🇰🇷 Seoul, Korea, Republic of