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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

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
KI1106 4g, QD
Atorvastatin Calcium 20mg, QD
Sponsored by
Kuhnil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Investigational Group- KI1106

    Control Group - Atorvastatin

    Arm Description

    KI1106 tablet - daily administration

    Atorvastatin Calcium 20mg - daily administration

    Outcomes

    Primary Outcome Measures

    Variation rate of Non HDL-C

    Secondary Outcome Measures

    Variation rate of TG
    Variation rate of Non HDL-C
    Variation rate of TC
    Variation rate of LDL-C
    Variation rate of VLDL-C
    Variation rate of Apo A-I
    Variation rate of Apo B

    Full Information

    First Posted
    March 23, 2018
    Last Updated
    November 15, 2018
    Sponsor
    Kuhnil Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03482180
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 4, 2016 (Actual)
    Primary Completion Date
    May 16, 2017 (Actual)
    Study Completion Date
    March 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kuhnil Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemias

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    215 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational Group- KI1106
    Arm Type
    Experimental
    Arm Description
    KI1106 tablet - daily administration
    Arm Title
    Control Group - Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin Calcium 20mg - daily administration
    Intervention Type
    Drug
    Intervention Name(s)
    KI1106 4g, QD
    Intervention Description
    KI1106 4 Capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin Calcium 20mg, QD
    Intervention Description
    Atorvastatin Calcium 20mg
    Primary Outcome Measure Information:
    Title
    Variation rate of Non HDL-C
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Variation rate of TG
    Time Frame
    4 weeks, 8 weeks
    Title
    Variation rate of Non HDL-C
    Time Frame
    4 weeks
    Title
    Variation rate of TC
    Time Frame
    4 weeks, 8 weeks
    Title
    Variation rate of LDL-C
    Time Frame
    4 weeks, 8 weeks
    Title
    Variation rate of VLDL-C
    Time Frame
    4 weeks, 8 weeks
    Title
    Variation rate of Apo A-I
    Time Frame
    4 weeks, 8 weeks
    Title
    Variation rate of Apo B
    Time Frame
    4 weeks, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    kyungshun Shin, Dr
    Organizational Affiliation
    manager
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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