Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
Phase 3
Completed
- Conditions
- Primary Hypercholesterolemia
- Interventions
- Drug: DP-R207 5/10mgDrug: DP-R207 10/10mgDrug: DP-R207 20/10mg
- Registration Number
- NCT02445352
- Lead Sponsor
- Alvogen Korea
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DP-R207 10/10mg & Placebo & Placebo Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks Rosuvastatin 5mg & Placebo & Placebo Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks Rosuvastatin 5mg & Placebo & Placebo Rosuvastatin 5mg Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks Rosuvastatin 5mg & Placebo & Placebo Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks DP-R207 5/10mg & Placebo & Placebo DP-R207 5/10mg Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks Rosuvastatin 20mg & Placebo & Placebo Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks DP-R207 5/10mg & Placebo & Placebo Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks Rosuvastatin 10mg & Placebo & Placebo Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks DP-R207 10/10mg & Placebo & Placebo Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks DP-R207 20/10mg & Placebo & Placebo Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks Rosuvastatin 10mg & Placebo & Placebo Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks DP-R207 5/10mg & Placebo & Placebo Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks DP-R207 10/10mg & Placebo & Placebo DP-R207 10/10mg Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks Rosuvastatin 20mg & Placebo & Placebo Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks DP-R207 20/10mg & Placebo & Placebo DP-R207 20/10mg Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks Rosuvastatin 20mg & Placebo & Placebo Rosuvastatin 20mg Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks DP-R207 20/10mg & Placebo & Placebo Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks Rosuvastatin 10mg & Placebo & Placebo Rosuvastatin 10mg Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
- Primary Outcome Measures
Name Time Method Percent change from baseline to 8 weeks in LDL-Cholesterol baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method Percent change from baseline to 8 weeks in lipid related blood test results baseline and 8 weeks Percent change from baseline to 4 weeks in lipid related blood test results baseline and 4 weeks Percent change from baseline to 4 weeks in LDL-Cholesterol baseline and 4 weeks Percentage of patients reaching treatment goals according to NCEP ATP III Guideline week 4 and week 8
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seodaemun-gu, Seoul, Korea, Republic of