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
Phase 3
Completed
- Conditions
- Dyslipidemias
- Interventions
- Drug: KI1106 4g, QD
- Registration Number
- NCT03482180
- Lead Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group - Atorvastatin Atorvastatin Calcium 20mg, QD Atorvastatin Calcium 20mg - daily administration Investigational Group- KI1106 KI1106 4g, QD KI1106 tablet - daily administration
- Primary Outcome Measures
Name Time Method Variation rate of Non HDL-C 8 weeks
- Secondary Outcome Measures
Name Time Method Variation rate of TG 4 weeks, 8 weeks 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 VLDL-C 4 weeks, 8 weeks Variation rate of Apo A-I 4 weeks, 8 weeks Variation rate of Apo B 4 weeks, 8 weeks