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A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia

Primary Purpose

Hypertension, Hyperlipidemias

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
(D) DWC202206
(D) DWC202207
(P) DWC202206
(P) DWC202207
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

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

Inclusion Criteria: Age 19 to 80 years Patients with hypertension and hyperlipidemias Exclusion Criteria: Orthostatic hypotension History of ventricular tachycardia, atrial fibrillation Uncontrolled diabetes mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    (D) DWC202206 + DWC202207

    (P+D) DWC202206 + DWC202207

    (D+P) DWC202206 + DWC202207

    Arm Description

    Outcomes

    Primary Outcome Measures

    The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
    The change of LDL-C based on baseline between treatment arm and control 2 arm

    Secondary Outcome Measures

    The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
    The change of LDL-C based on baseline between treatment arm and control 2 arm

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    December 8, 2022
    Sponsor
    Daewoong Pharmaceutical Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05643508
    Brief Title
    A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia
    Official Title
    A Randomized, Double-blind, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Hypertension and Dyslipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (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
    This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.
    Detailed Description
    The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    (D) DWC202206 + DWC202207
    Arm Type
    Experimental
    Arm Title
    (P+D) DWC202206 + DWC202207
    Arm Type
    Active Comparator
    Arm Title
    (D+P) DWC202206 + DWC202207
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    (D) DWC202206
    Intervention Description
    Drug of DWC202206 A mg
    Intervention Type
    Drug
    Intervention Name(s)
    (D) DWC202207
    Intervention Description
    Drug of DWC202207 B/C mg
    Intervention Type
    Drug
    Intervention Name(s)
    (P) DWC202206
    Intervention Description
    Placebo of DWC202206 A mg
    Intervention Type
    Drug
    Intervention Name(s)
    (P) DWC202207
    Intervention Description
    Placebo of DWC202207 B/C mg
    Primary Outcome Measure Information:
    Title
    The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
    Time Frame
    8 weeks
    Title
    The change of LDL-C based on baseline between treatment arm and control 2 arm
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
    Time Frame
    4 weeks
    Title
    The change of LDL-C based on baseline between treatment arm and control 2 arm
    Time Frame
    4 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: Age 19 to 80 years Patients with hypertension and hyperlipidemias Exclusion Criteria: Orthostatic hypotension History of ventricular tachycardia, atrial fibrillation Uncontrolled diabetes mellitus

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia

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