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

• Status: Completed
• Trial end date: 2018-03-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium; Calcium, Dietary

Criteria

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