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

July 15, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

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 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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-8159
Udenafil(The study had one arm.)
Drug: DA-8159 (Udenafil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
Time Frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)

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)

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: 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
  • Principal Investigator: W S Chung, MD, PhD, Ewha Womans University 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

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_EDDL_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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