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: Atorvastatin Calcium 20mg, QD; 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.

Study Timeline

• Study Start: 2016-05-04
• Primary Completion: 2017-05-16
• Status Verified: 2018-03
• Study Completion: 2018-03-23
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-29
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

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