search
Back to results

Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DA-8159 (Udenafil)
Placebo
Sponsored by
Dong-A Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients aged 20 years or more diagnosed with ED

Exclusion Criteria:

  • Had uncontrolled blood pressure
  • Had hepatic or renal dysfunction
  • Was currently under anticancer chemotherapy
  • Had a treatments for ED using other PDE-5 inhibitors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    DA-8159 dose 1

    DA-8159 dose 2

    Placebo

    Arm Description

    Udenafil

    Udenafil

    Outcomes

    Primary Outcome Measures

    IIEF EF domain score

    Secondary Outcome Measures

    IIEF, IPSS

    Full Information

    First Posted
    January 22, 2013
    Last Updated
    January 23, 2013
    Sponsor
    Dong-A Pharmaceutical Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01774864
    Brief Title
    Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction
    Official Title
    Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dong-A Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study Design : multi-center, double-blind, placebo-controlled, randomized, parallel group, fixed dose design Phase : Phase III

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DA-8159 dose 1
    Arm Type
    Experimental
    Arm Description
    Udenafil
    Arm Title
    DA-8159 dose 2
    Arm Type
    Experimental
    Arm Description
    Udenafil
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    DA-8159 (Udenafil)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    IIEF EF domain score
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    IIEF, IPSS
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients aged 20 years or more diagnosed with ED Exclusion Criteria: Had uncontrolled blood pressure Had hepatic or renal dysfunction Was currently under anticancer chemotherapy Had a treatments for ED using other PDE-5 inhibitors
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    S W Kim, MD, PhD
    Organizational Affiliation
    the Catholic University of Korea St. Mary's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    D G Moon, MD, PhD
    Organizational Affiliation
    Korea University Guro Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    J J Kim, MD, PhD
    Organizational Affiliation
    Korea University Anam Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    N C Park, MD, PhD
    Organizational Affiliation
    Pusan National University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    S W Lee, MD, PhD
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    J S Paick, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    T Y Ahn, MD, PhD
    Organizational Affiliation
    Asan Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    K H Moon, MD, PhD
    Organizational Affiliation
    Yeungnam University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    W S Chung, MD, PhD
    Organizational Affiliation
    Ewha Womans University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    K S Min, MD, PhD
    Organizational Affiliation
    Inje University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    J K Park, MD, PhD
    Organizational Affiliation
    Chonbuk National University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    D Y Yang, MD, PhD
    Organizational Affiliation
    Kangdong Sacred Heart Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

    We'll reach out to this number within 24 hrs