The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
374
1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ ●: HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab.5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ ○: HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
Percentage change in LDL-Cholesterol from baseline
Percentage change(%) in LDL-Cholesterol from baseline at week 8
Time frame: Week 8
Percentage change in LDL-Cholesterol from baseline
Percentage change(%) in LDL-Cholesterol from baseline at week 4
Time frame: Week 4
Percentage change in TG from baseline
Percentage change(%) in TG from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage change in TC from baseline
Percentage change(%) in TC from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage of change in non-HDL-Cholesterol
Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage of change in HDL-Cholesterol
Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage of change weeks in Apo A-I
Percentage change(%) in Apo A-I from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage of change in Apo B
Percentage change(%) in Apo B from baseline at week 4 and week 8
Time frame: Week 4, Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 5mg : ○♤♡■△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo,♡: HL140 20/10mg placebo, ■: Crestor Tab. 5mg, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL1405/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ * HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 10mg : ○♤♡□▲◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, ▲: Crestor Tab. 10mg, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ * HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
1. Treatment(W0\~W8): 6Tab./q.d.Rosuvastatin 20mg : ○♤♡□△◆ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◆: Crestor Tab. 20mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
Percentage of change in Lipoprotein(a)
Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8
Time frame: Week 4, Week 8
The rate of change in hs-CRP
Percentage change(%) in hs-CRP from baseline at week 4 and week 8
Time frame: Week 4, Week 8
Percentage of patients reached treatment goals according to NCEP ATP III Guideline
Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8
Time frame: Week 4, Week 8