Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01774864
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.:

Primary Outcome Measures:
  • IIEF EF domain score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IIEF, IPSS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774864

Sponsors and Collaborators
Dong-A ST 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
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

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01774864     History of Changes
Other Study ID Numbers: DA8159_EDD_III
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on October 22, 2014