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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06153433

Enrollment

112

Registered

2023-12-01

Start date

2023-11-06

Completion date

2024-08-31

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

dyslipidemia, orally disintegrating tablet, odt, rosuvastatin, preference

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

Interventions

DRUGRosuvastatin Immediate-Release Tablet (IRT) 10mg

Rosuvastatin Immediate-Release Tablet (IRT) 10mg

DRUGRosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in Total Cholesterol (TC) from Baseline after treatment of each formulation for 8 week	Week 0, 8, 16
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

Countries

South Korea

Contacts

Primary ContactJung-Sun Kim

kjs1218@yuhs.ac+82-2-2228-8457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026