Status:
UNKNOWN
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
Lead Sponsor:
Yonsei University
Conditions:
Dyslipidemia
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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, th...
Eligibility Criteria
Inclusion
- Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
- Written informed consent to participate in the trial
Exclusion
- History of previous hypersensitivity reaction to other statins, including rosuvastatin
- patients with acute arterial disease within 3 months
- Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
- Uncontrolled diabetes mellitus (HbA1c \> 9%)
- Uncontrolled hypothyroidism defined as TSH \>1.5 within the last 6 months
- Taking other lipid lowering agent except statins
- History of statin-induced myopathy, rhabdomyolysis
- Patients with severe hepatic or renal dysfunction
- BMI (body mass index) \> 40 kg/m2
- history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06153433
Start Date
November 6 2023
End Date
August 1 2024
Last Update
December 1 2023
Active Locations (1)
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1
Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity,
Seoul, South Korea