Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

January 23, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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

parallel group, fixed dose design

Phase : Phase III

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: DA-8159 dose 1
Udenafil
Drug: DA-8159 (Udenafil)
Experimental: DA-8159 dose 2
Udenafil
Drug: DA-8159 (Udenafil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IIEF EF domain score
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
IIEF, IPSS
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: S W Kim, MD, PhD, The Catholic University of Korea St. Mary's Hospital
  • Principal Investigator: D G Moon, MD, PhD, Korea University Guro Hospital
  • Principal Investigator: J J Kim, MD, PhD, Korea University Anam Hospital
  • Principal Investigator: N C Park, MD, PhD, Pusan National University Hospital
  • Principal Investigator: S W Lee, MD, PhD, Samsung Medical Center
  • Principal Investigator: J S Paick, MD, PhD, Seoul National University Hospital
  • Principal Investigator: T Y Ahn, MD, PhD, Asan Medical Center
  • Principal Investigator: K H Moon, MD, PhD, Yeungnam University Hospital
  • Principal Investigator: W S Chung, MD, PhD, Ewha Womans University
  • Principal Investigator: K S Min, MD, PhD, Inje University
  • Principal Investigator: J K Park, MD, PhD, Chonbuk National University Hospital
  • Principal Investigator: D Y Yang, MD, PhD, Kangdong Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_EDD_III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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