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Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled (ROMANTIC)

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
KI1107 4 Capsules, QD
Rosuvastatin Calcium 20 MG, 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

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

Inclusion criteria:

  • Screening Visit

    • Age: 19-80
    • High risk for cardiovascular disease according to NCEP APT III
    • TG≥130mg/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 dompairng screening visit

Exclusion criteria:

  • The patient has histories of acute artery disease within 3 months
  • The patient has histories of operation revasculatiation or aneurysm within 6 months
  • The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
  • The patient has histories of Effectable disease to the procedrue and clinical trial result

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment

    Control

    Arm Description

    KI1107

    Rosuvastatin calcium

    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
    January 16, 2017
    Last Updated
    January 19, 2017
    Sponsor
    Kuhnil Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03026933
    Brief Title
    Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
    Acronym
    ROMANTIC
    Official Title
    A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
    Detailed Description
    Study design: Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin 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
    Treatment
    Arm Type
    Experimental
    Arm Description
    KI1107
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Rosuvastatin calcium
    Intervention Type
    Drug
    Intervention Name(s)
    KI1107 4 Capsules, QD
    Intervention Description
    KI1107 4 Capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin Calcium 20 MG, QD
    Intervention Description
    Rosuvastatin Calcium 20mg, QD
    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
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Screening Visit Age: 19-80 High risk for cardiovascular disease according to NCEP APT III TG≥130mg/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 dompairng screening visit Exclusion criteria: The patient has histories of acute artery disease within 3 months The patient has histories of operation revasculatiation or aneurysm within 6 months The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis The patient has histories of Effectable disease to the procedrue and clinical trial result

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29223557
    Citation
    Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.
    Results Reference
    derived

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    Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

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