NCT01774864

Brief Summary

Study Design : multi-center, double-blind, placebo-controlled, randomized, parallel group, fixed dose design Phase : Phase III

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

January 22, 2013

Last Update Submit

January 23, 2013

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • IIEF EF domain score

    24 weeks

Secondary Outcomes (1)

  • IIEF, IPSS

    24 weeks

Study Arms (3)

DA-8159 dose 1

EXPERIMENTAL

Udenafil

Drug: DA-8159 (Udenafil)

DA-8159 dose 2

EXPERIMENTAL

Udenafil

Drug: DA-8159 (Udenafil)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DA-8159 (Udenafil)DRUG
DA-8159 dose 1DA-8159 dose 2
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients aged 20 years or more diagnosed with ED

You may not qualify if:

  • Had uncontrolled blood pressure
  • Had hepatic or renal dysfunction
  • Was currently under anticancer chemotherapy
  • Had a treatments for ED using other PDE-5 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

udenafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01