Primary Hypercholesterolemia
Conditions
Brief summary
The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
Detailed description
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
Interventions
DRUGHL140 5/10
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
DRUGHL140 10/10
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
DRUGHL140 20/10
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
DRUGRosuvastatin 5mg → HL140 5/10
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
DRUGRosuvastatin 10mg → HL140 10/10
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
DRUGRosuvastatin 20mg → HL140 20/10
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
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged over 19 years * Signed informed consent form * At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL
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 diabetes mellitus(HbA1c ≥9%) * Hypothyroidism (TSH \> 1.5 x upper limit of normal rate at the screening ) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in LDL-Cholesterol from baseline | Week 8 | Percentage change(%) in LDL-Cholesterol from baseline at week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in TG from baseline | Week 4, Week 8 | Percentage change(%) in TG from baseline at week 4 and week 8 |
| Percentage change in TC from baseline | Week 4, Week 8 | Percentage change(%) in TC from baseline at week 4 and week 8 |
| Percentage of change in non-HDL-Cholesterol | Week 4, Week 8 | Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8 |
| Percentage of change in HDL-Cholesterol | Week 4, Week 8 | Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8 |
| Percentage change in LDL-Cholesterol from baseline | Week 4 | Percentage change(%) in LDL-Cholesterol from baseline at week 4 |
| Percentage of change in Apo B | Week 4, Week 8 | Percentage change(%) in Apo B from baseline at week 4 and week 8 |
| Percentage of change in Lipoprotein(a) | Week 4, Week 8 | Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8 |
| The rate of change in hs-CRP | Week 4, Week 8 | Percentage change(%) in hs-CRP from baseline at week 4 and week 8 |
| Percentage of patients reached treatment goals according to NCEP ATP III Guideline | Week 4, Week 8 | Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8 |
| Percentage of change weeks in Apo A-I | Week 4, Week 8 | Percentage change(%) in Apo A-I from baseline at week 4 and week 8 |
Outcome results
None listed