Trials / Completed
CompletedNCT01901640
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Dong-A Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DA-8159 (Udenafil) |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2013-07-17
- Last updated
- 2013-07-17
Source: ClinicalTrials.gov record NCT01901640. Inclusion in this directory is not an endorsement.