Status:
COMPLETED
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
Lead Sponsor:
Yuhan Corporation
Conditions:
Type 2 Diabetes Mellitus
Hypercholesterolemia
Eligibility:
All Genders
19-70 years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Aged 19 to 70 years
- Patient with type 2 diabetes who needs treatment for hypercholesterolemia
- Written informed consent
Exclusion
- Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
- Uncontrollable diabetes with HbA1c ≥ 8.5%
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 400 mg/dL
- Total cholesterol ≥ 300 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to rosuvastatin or ezetemibe
- 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
- Administration of other investigational products within 30 days prior to screening visit
- Other than the above who is deemed to be ineligible to participate in the trial by investigator
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03446261
Start Date
February 23 2018
End Date
March 5 2019
Last Update
July 23 2019
Active Locations (2)
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1
Asan Medical Center
Kora-ri, South Korea
2
Asan Medical Center
Seoul, South Korea, 05505