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Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Primary Purpose

Dyslipidemias

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DKP21102_C
DKP21102_B
DKP21102_A
Sponsored by
Dongkwang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

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

Inclusion Criteria: A man or woman over 19 years old. Patients with coronary heart disease or risk of coronary heart disease Exclusion Criteria: History of Unstable angina, myocardial infarction etc Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%) renal impairment (Creatinine clearance < 60 mL/min) etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Treatment group

    Arm Description

    DKP21102_A, DKP21102_C

    DKP21102_A, DKP21102_B

    Outcomes

    Primary Outcome Measures

    Percent change (%) of non-HDL-C from baseline
    non-HDL-C

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    April 12, 2023
    Sponsor
    Dongkwang Pharm. Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05809687
    Brief Title
    Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A
    Official Title
    Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dongkwang Pharm. Co., Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A
    Detailed Description
    Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

    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
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double-blind
    Allocation
    Randomized
    Enrollment
    512 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    DKP21102_A, DKP21102_C
    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    DKP21102_A, DKP21102_B
    Intervention Type
    Drug
    Intervention Name(s)
    DKP21102_C
    Intervention Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    DKP21102_B
    Intervention Description
    Treatment
    Intervention Type
    Drug
    Intervention Name(s)
    DKP21102_A
    Intervention Description
    Active Control
    Primary Outcome Measure Information:
    Title
    Percent change (%) of non-HDL-C from baseline
    Description
    non-HDL-C
    Time Frame
    from baseline at 12weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A man or woman over 19 years old. Patients with coronary heart disease or risk of coronary heart disease Exclusion Criteria: History of Unstable angina, myocardial infarction etc Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%) renal impairment (Creatinine clearance < 60 mL/min) etc.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

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