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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
Full 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 and hypercholesterolemia.
Enrollment
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Inclusion criteria
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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