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

Dyslipidemias Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482180
• Other study ID #: 12-OA-8301
• Status: Completed
• Phase: Phase 3
• Start date: May 4, 2016
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2018
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 23, 2018
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• KI1106 4g, QD
KI1106 4 Capsules
• Atorvastatin Calcium 20mg, QD
Atorvastatin Calcium 20mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation rate of Non HDL-C		8 weeks
Secondary	Variation rate of TG		4 weeks, 8 weeks
Secondary	Variation rate of Non HDL-C		4 weeks
Secondary	Variation rate of TC		4 weeks, 8 weeks
Secondary	Variation rate of LDL-C		4 weeks, 8 weeks
Secondary	Variation rate of VLDL-C		4 weeks, 8 weeks
Secondary	Variation rate of Apo A-I		4 weeks, 8 weeks
Secondary	Variation rate of Apo B		4 weeks, 8 weeks