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Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Primary Purpose

Dyslipidemias

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DWJ1506
DWJ1507
DWC202011
DWJ1177
Sponsored by
Daewoong 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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults aged 19 years or over
  2. Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL
  3. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

  1. Severe congestive hear failure
  2. Current active liver disease
  3. The use of prohibiterd concomitant therapies
  4. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.

6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    DWJ1506

    DWJ1507

    DWC202011

    DWJ1177

    Arm Description

    Outcomes

    Primary Outcome Measures

    LDL-C levels at week 8
    Change from baseline in LDL-C level at week 8 after administration of the IP

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2021
    Last Updated
    February 24, 2021
    Sponsor
    Daewoong Pharmaceutical Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04772443
    Brief Title
    Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
    Official Title
    A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewoong 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
    The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.

    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
    Allocation
    Randomized
    Enrollment
    280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DWJ1506
    Arm Type
    Experimental
    Arm Title
    DWJ1507
    Arm Type
    Experimental
    Arm Title
    DWC202011
    Arm Type
    Active Comparator
    Arm Title
    DWJ1177
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    DWJ1506
    Intervention Description
    DWJ1506
    Intervention Type
    Drug
    Intervention Name(s)
    DWJ1507
    Intervention Description
    DWJ1507
    Intervention Type
    Drug
    Intervention Name(s)
    DWC202011
    Intervention Description
    DWC202011
    Intervention Type
    Drug
    Intervention Name(s)
    DWJ1177
    Intervention Description
    DWC202011
    Primary Outcome Measure Information:
    Title
    LDL-C levels at week 8
    Description
    Change from baseline in LDL-C level at week 8 after administration of the IP
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults aged 19 years or over Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Severe congestive hear failure Current active liver disease The use of prohibiterd concomitant therapies Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

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