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
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 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
NCT ID
NCT01901640
First Posted
January 22, 2013
Last Updated
July 15, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
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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