Dyslipidemias
Conditions
Brief summary
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Detailed description
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
Interventions
DRUGKI1106 4g, QD
KI1106 4 Capsules
DRUGAtorvastatin Calcium 20mg, QD
Atorvastatin Calcium 20mg
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Screening Visit * Age: 20-80 * High risk for cardiovascular disease according to NCEP APT III * TG≥300mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks * 500mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks * Baseline Visit * 500mg/dL\>TG≥200mg/dL * LDL-C\<110mg/dL * Reduction of LDL-C comparing screening visit
Exclusion criteria
* The patient has histories of acute artery disease within 3 months * The patient has histories of operation revasculariation or aneurysm within 6 months * The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis * The patient has histories of effect able disease to the procedure and clinical trial result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation rate of Non HDL-C | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Variation rate of Non HDL-C | 4 weeks |
| Variation rate of TC | 4 weeks, 8 weeks |
| Variation rate of LDL-C | 4 weeks, 8 weeks |
| Variation rate of TG | 4 weeks, 8 weeks |
| Variation rate of Apo A-I | 4 weeks, 8 weeks |
| Variation rate of Apo B | 4 weeks, 8 weeks |
| Variation rate of VLDL-C | 4 weeks, 8 weeks |
Outcome results
None listed