Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

NCT ID: NCT01774864

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DA-8159 dose 1

Udenafil

Group Type EXPERIMENTAL

DA-8159 (Udenafil)

Intervention Type DRUG

DA-8159 dose 2

Udenafil

Group Type EXPERIMENTAL

DA-8159 (Udenafil)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DA-8159 (Udenafil)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S W Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

the Catholic University of Korea St. Mary's Hospital

D G Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

J J Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

N C Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

S W Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

J S Paick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

T Y Ahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

K H Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

W S Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

K S Min, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

J K Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

D Y Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kangdong Sacred Heart Hospital

Other Identifiers

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DA8159_EDD_III

Identifier Type: -

Identifier Source: org_study_id

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