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Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DA-8159 (Udenafil)
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 erectile dysfunction(ED)

Exclusion Criteria:

  • Had uncontrolled blood pressure
  • Had hepatic or renal dysfunction
  • Had significant psychiatric disorders or drug abuses
  • Was currently under anticancer chemotherapy
  • Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DA-8159

    Arm Description

    Udenafil(The study had one arm.)

    Outcomes

    Primary Outcome Measures

    Safety
    Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.

    Secondary Outcome Measures

    International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
    The efficacy measures(Unit of Measure) IIEF EF domain score(Change from baseline) IIEF other domain scores(Change from baseline) GAQ & Shift to normal(percentage of subject)

    Full Information

    First Posted
    January 22, 2013
    Last Updated
    July 15, 2013
    Sponsor
    Dong-A Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01901640
    Brief Title
    Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction
    Official Title
    Phase 3 Study to Evaluate Longterm 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
    November 2011 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    November 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
    Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)
    Detailed Description
    Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    302 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DA-8159
    Arm Type
    Experimental
    Arm Description
    Udenafil(The study had one arm.)
    Intervention Type
    Drug
    Intervention Name(s)
    DA-8159 (Udenafil)
    Primary Outcome Measure Information:
    Title
    Safety
    Description
    Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.
    Time Frame
    48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
    Secondary Outcome Measure Information:
    Title
    International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
    Description
    The efficacy measures(Unit of Measure) IIEF EF domain score(Change from baseline) IIEF other domain scores(Change from baseline) GAQ & Shift to normal(percentage of subject)
    Time Frame
    48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)

    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 erectile dysfunction(ED) Exclusion Criteria: Had uncontrolled blood pressure Had hepatic or renal dysfunction Had significant psychiatric disorders or drug abuses Was currently under anticancer chemotherapy Had a treatments for ED using other phosphodiesterase type 5(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 Hospital
    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

    Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

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