Dyslipidemias
Conditions
Brief summary
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
Detailed description
Study design: Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.
Interventions
DRUGKI1107 4 Capsules, QD
KI1107 4 Capsules
DRUGRosuvastatin Calcium 20 MG, QD
Rosuvastatin Calcium 20mg, QD
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Screening Visit * Age: 19-80 * High risk for cardiovascular disease according to NCEP APT III * TG≥130mg/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 dompairng screening visit
Exclusion criteria
* The patient has histories of acute artery disease within 3 months * The patient has histories of operation revasculatiation or aneurysm within 6 months * The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis * The patient has histories of Effectable disease to the procedrue 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