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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL140 5/10 | Experimental | Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) |
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| HL140 10/10 | Experimental | Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) |
|
| HL140 20/10 | Experimental | Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) |
|
| Rosuvastatin 5mg → HL140 5/10 | Experimental |
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| Rosuvastatin 10mg → HL140 10/10 | Experimental |
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| Rosuvastatin 20mg → HL140 20/10 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL140 5/10 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-Cholesterol from baseline | Percentage change(%) in LDL-Cholesterol from baseline at week 8 | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-Cholesterol from baseline | Percentage change(%) in LDL-Cholesterol from baseline at week 4 | Week 4 |
| Percentage change in TG from baseline | Percentage change(%) in TG from baseline at week 4 and week 8 |
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Inclusion Criteria:
Exclusion Criteria:
At visit 1, BMI ≥ 30kg/㎡
Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
Creatine Kinase > 5 x upper limit of normal
ALT or AST > 3 x upper limit of normal
Has a activity/chronic hepatic disease or HIV-positive
Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein
Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
Severe heart failure (NYHA Class III or IV)
Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
Pregnant or breast-feeding
Patients who have a drug or alcohol abuse or are being treated for psychological disorder
Patients who were treated with other investigational drug within 12 weeks prior to screening
Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs
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| Name | Affiliation | Role |
|---|---|---|
| Kisik Kim | The Catholic University of Korea, Dagu St. Mary's Hospital | Study Chair |
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| Experimental |
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| HL140 10/10 | Drug | 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 |
|
| HL140 20/10 | Drug | 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 |
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| Rosuvastatin 5mg → HL140 5/10 | Drug |
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| Rosuvastatin 10mg → HL140 10/10 | Drug |
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| Rosuvastatin 20mg → HL140 20/10 | Drug |
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| Week 4, Week 8 |
| Percentage change in TC from baseline | Percentage change(%) in TC from baseline at week 4 and week 8 | 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 | Week 4, Week 8 |
| Percentage of change in HDL-Cholesterol | Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8 | 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 | Week 4, Week 8 |
| Percentage of change in Apo B | Percentage change(%) in Apo B from baseline at week 4 and week 8 | Week 4, Week 8 |
| Percentage of change in Lipoprotein(a) | Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8 | Week 4, Week 8 |
| The rate of change in hs-CRP | Percentage change(%) in hs-CRP from baseline at week 4 and week 8 | 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 | Week 4, Week 8 |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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