Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction
Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction
1 other identifier
interventional
302
0 countries
N/A
Brief Summary
Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159\_EDD\_III)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedJuly 17, 2013
January 1, 2013
1 year
January 22, 2013
July 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.
48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Secondary Outcomes (1)
International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Study Arms (1)
DA-8159
EXPERIMENTALUdenafil(The study had one arm.)
Interventions
Eligibility Criteria
You may qualify if:
- Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
S W Kim, MD, PhD
the Catholic University of Korea St. Mary's Hospital
- PRINCIPAL INVESTIGATOR
D G Moon, MD, PhD
Korea University Guro Hospital
- PRINCIPAL INVESTIGATOR
J J Kim, MD, PhD
Korea University Anam Hospital
- PRINCIPAL INVESTIGATOR
N C Park, MD, PhD
Pusan National University Hospital
- PRINCIPAL INVESTIGATOR
S W Lee, MD, PhD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
J S Paick, MD, PhD
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
T Y Ahn, MD, PhD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
K H Moon, MD, PhD
Yeungnam University Hospital
- PRINCIPAL INVESTIGATOR
W S Chung, MD, PhD
Ewha Womans University Hospital
- PRINCIPAL INVESTIGATOR
K S Min, MD, PhD
Inje University
- PRINCIPAL INVESTIGATOR
J K Park, MD, PhD
Chonbuk National University Hospital
- PRINCIPAL INVESTIGATOR
D Y Yang, MD, PhD
Kangdong Sacred Heart Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2013
First Posted
July 17, 2013
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
July 17, 2013
Record last verified: 2013-01