Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: Rosuvastatin 5mg
* Drug: DP-R207 5/10mg
* Drug: Rosuvastatin 10mg
* Drug: DP-R207 10/10mg
* Drug: Rosuvastatin 20mg
* Drug: DP-R207 20/10mg
* Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
* Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
* Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 19 years Signed informed consent form At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL Exclusion Criteria: Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe Liver transaminases > 2 x upper limit of normal

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin 5mg & Placebo & Placebo<br>Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks | Drug: Rosuvastatin 5mg<br> <br> Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)<br> <br> |
| Experimental: DP-R207 5/10mg & Placebo & Placebo<br>Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks | Drug: DP-R207 5/10mg<br> <br> * Other names: Ezetimibe 10mg;Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)<br> <br> |
| Active Comparator: Rosuvastatin 10mg & Placebo & Placebo<br>Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks | Drug: Rosuvastatin 10mg<br> <br> Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)<br> <br> |
| Experimental: DP-R207 10/10mg & Placebo & Placebo<br>Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks | Drug: DP-R207 10/10mg<br> <br> * Other names: Ezetimibe 10mg;Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)<br> <br> |
| Active Comparator: Rosuvastatin 20mg & Placebo & Placebo<br>Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks | Drug: Rosuvastatin 20mg<br> <br> Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)<br> <br> |
| Experimental: DP-R207 20/10mg & Placebo & Placebo<br>Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks | Drug: DP-R207 20/10mg<br> <br> * Other names: Ezetimibe 10mg;Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)<br> <br> Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 8 weeks in LDL-Cholesterol |  | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 4 weeks in LDL-Cholesterol |  | baseline and 4 weeks | 
| Percent change from baseline to 4 weeks in lipid related blood test results |  | baseline and 4 weeks | 
| Percent change from baseline to 8 weeks in lipid related blood test results |  | baseline and 8 weeks | 
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline |  | week 4 and week 8 |