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
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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
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
NCT ID
NCT01774864
First Posted
January 22, 2013
Last Updated
January 23, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
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
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