Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

Launched by YUHAN CORPORATION · Feb 20, 2018

Keywords

ClinConnect Summary

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 19 to 70 years
• • 2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
• • 3. Written informed consent
• Exclusion Criteria:
• • 1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
• • 2. Uncontrollable diabetes with HbA1c ≥ 8.5%
• • 3. Fasting LDL-C ≤ 70 mg/dL
• • 4. Fasting triglyceride ≥ 400 mg/dL
• • 5. Total cholesterol ≥ 300 mg/dL
• • 6. History of muscular disease or rhabdomyolysis due to use of statin
• • 7. Hypersensitive to rosuvastatin or ezetemibe
• 8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
• • ① Severe renal disease (estimated GFR(MDRD) \< 30mL/min/1.73m2)
• • ② ALT, AST \> 3x ULN or history of active liver disease
• • ③ CPK \> 3x ULN
• • 9. Administration of other investigational products within 30 days prior to screening visit
• • 10. Other than the above who is deemed to be ineligible to participate in the trial by investigator