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

NCT ID: NCT01901640

Last Updated: 2013-07-17

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

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159\_EDD\_III)

Detailed Description

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DA-8159

Udenafil(The study had one arm.)

Group Type EXPERIMENTAL

DA-8159 (Udenafil)

Intervention Type DRUG

Interventions

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DA-8159 (Udenafil)

Intervention Type DRUG

Eligibility Criteria

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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
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 Hospital

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_EDDL_III

Identifier Type: -

Identifier Source: org_study_id

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