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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 16, 2017

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Investigational Group- KI1106
    • KI1106 tablet – daily administration
  • Active Comparator: Control Group – Atorvastatin
    • Atorvastatin Calcium 20mg – daily administration

Clinical Trial Outcome Measures

Primary Measures

  • Variation rate of Non HDL-C
    • Time Frame: 8 weeks

Secondary Measures

  • Variation rate of TG
    • Time Frame: 4 weeks, 8 weeks
  • Variation rate of Non HDL-C
    • Time Frame: 4 weeks
  • Variation rate of TC
    • Time Frame: 4 weeks, 8 weeks
  • Variation rate of LDL-C
    • Time Frame: 4 weeks, 8 weeks
  • Variation rate of VLDL-C
    • Time Frame: 4 weeks, 8 weeks
  • Variation rate of Apo A-I
    • Time Frame: 4 weeks, 8 weeks
  • Variation rate of Apo B
    • Time Frame: 4 weeks, 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kuhnil Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • kyungshun Shin, Dr, Study Director, manager

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