Status:
COMPLETED
Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01901640
Start Date
November 1 2011
End Date
November 1 2012
Last Update
July 17 2013
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