Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901640
• Other study ID #: DA8159_EDDL_III
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2013
• Last updated: July 15, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

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 information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• DA-8159 (Udenafil)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)	No