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

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ClinicalTrials.gov Identifier: NCT01901640
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: DA-8159 (Udenafil) Phase 3

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  (Clinical Trial)
Actual Enrollment : 302 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



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

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

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): NCT01901640


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 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

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01901640     History of Changes
Other Study ID Numbers: DA8159_EDDL_III
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: July 17, 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