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Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

Primary Purpose

Hypertension, Hypercholesterolemia

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DP-R212
C1-R212
C2-R212
Sponsored by
Alvogen Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring DP-R212

Eligibility Criteria

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

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Hypertension patient with hypercholesterolemia

Exclusion Criteria:

  • sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
  • A history of cardiovascular disease
  • rhabdomyolysis, myopathy
  • Hypertension or hypercholesterolemia due to secondary causes
  • Uncontrolled diabetes
  • Evidence of hepatic or renal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    DP-R212 group

    C1-R212 group

    C2-R212 group

    Arm Description

    DP-R212 + C1-R212 placebo + C2-R212 placebo

    DP-R212 placebo + C1-R212 + C2-R212 placebo

    DP-R212 placebo + C1-R212 placebo + C2-R212

    Outcomes

    Primary Outcome Measures

    Percent change of LDL-Cholesterol
    Change of mean seated Systolic Blood Pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2016
    Last Updated
    June 1, 2017
    Sponsor
    Alvogen Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02955368
    Brief Title
    Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
    Official Title
    A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Canceled
    Study Start Date
    February 2017 (Anticipated)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alvogen Korea

    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 superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hypercholesterolemia
    Keywords
    DP-R212

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DP-R212 group
    Arm Type
    Experimental
    Arm Description
    DP-R212 + C1-R212 placebo + C2-R212 placebo
    Arm Title
    C1-R212 group
    Arm Type
    Active Comparator
    Arm Description
    DP-R212 placebo + C1-R212 + C2-R212 placebo
    Arm Title
    C2-R212 group
    Arm Type
    Active Comparator
    Arm Description
    DP-R212 placebo + C1-R212 placebo + C2-R212
    Intervention Type
    Drug
    Intervention Name(s)
    DP-R212
    Intervention Description
    DP-R212 + C1-R212 placebo + C2-R212 placebo
    Intervention Type
    Drug
    Intervention Name(s)
    C1-R212
    Intervention Description
    DP-R212 placebo + C1-R212 + C2-R212 placebo
    Intervention Type
    Drug
    Intervention Name(s)
    C2-R212
    Intervention Description
    DP-R212 placebo + C1-R212 placebo + C2-R212
    Primary Outcome Measure Information:
    Title
    Percent change of LDL-Cholesterol
    Time Frame
    0, 8 weeks
    Title
    Change of mean seated Systolic Blood Pressure
    Time Frame
    0, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both man and woman who is over 19 years old Hypertension patient with hypercholesterolemia Exclusion Criteria: sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg A history of cardiovascular disease rhabdomyolysis, myopathy Hypertension or hypercholesterolemia due to secondary causes Uncontrolled diabetes Evidence of hepatic or renal disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

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