Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: DA-8159 (Udenafil)
- Registration Number
- NCT01901640
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 302
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DA-8159 DA-8159 (Udenafil) Udenafil(The study had one arm.)
- Primary Outcome Measures
Name Time Method Safety 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study) 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
Name Time Method 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) 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)