The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
Phase 3
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: Rosuvastatin/Ezetimibe
- Registration Number
- NCT02251847
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- Brief Summary
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
- Detailed Description
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Hypercholesterolemic patient
Exclusion Criteria
- Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R5 Rosuvastatin/Ezetimibe Rosuvastatin 5mg R10/E10 Rosuvastatin/Ezetimibe Rosuvastatin 10mg/ezetimibe 10mg R20/E10 Rosuvastatin/Ezetimibe Rosuvastatin 20mg/ezetimibe 10mg R20 Rosuvastatin/Ezetimibe Rosuvastatin 20mg R10 Rosuvastatin/Ezetimibe Rosuvastatin 10mg R5/E10 Rosuvastatin/Ezetimibe Rosuvastatin 5mg/ezetimibe 10mg
- Primary Outcome Measures
Name Time Method Percent change from baseline to 8 week in LDL-Cholesterol baseline and 8 week
- Secondary Outcome Measures
Name Time Method Percent change from baseline to 4 week in LDL-Cholesterol baseline and 4 week
Trial Locations
- Locations (1)
Gil Medical Center
🇰🇷Seoul, Korea, Republic of