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Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774864
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )
  Purpose

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

parallel group, fixed dose design

Phase : Phase III


Condition Intervention Phase
Erectile Dysfunction Drug: DA-8159 (Udenafil) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

Primary Outcome Measures:
  • IIEF EF domain score [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • IIEF, IPSS [ Time Frame: 24 weeks ]

Enrollment: 349
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-8159 dose 1
Udenafil
Drug: DA-8159 (Udenafil)
Experimental: DA-8159 dose 2
Udenafil
Drug: DA-8159 (Udenafil)
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774864


Sponsors and Collaborators
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
  More Information

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01774864     History of Changes
Other Study ID Numbers: DA8159_EDD_III
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action