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Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01774864
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Dong-A Pharmaceutical 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 Pharmaceutical 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
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
 Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013