Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled

Kuhnil Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Dyslipidemias

Treatments

Drug: KI1106 4g, QD

Drug: Atorvastatin Calcium 20mg, QD

Study type

Interventional

Funder types

Industry

Identifiers

12-OA-8301

Details and patient eligibility

About

To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.

Full description

Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.

Enrollment

215 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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