Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774864
• Other study ID #: DA8159_EDD_III
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2013
• Last updated: January 23, 2013
• Start date: April 2011
• Est. completion date: May 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

Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: May 2012
• Est. primary completion date: May 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 ED

Exclusion Criteria:

• Had uncontrolled blood pressure

• Had hepatic or renal dysfunction

• Was currently under anticancer chemotherapy

• Had a treatments for ED using other PDE-5 inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• DA-8159 (Udenafil)

• Placebo

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	IIEF EF domain score		24 weeks	No
Secondary	IIEF, IPSS		24 weeks	No