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OpenTrials
Completed

NCT Number: NCT01901640

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

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-8159 (Udenafil)

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 17, 2013
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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