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Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH

NCT ID: NCT02304198

Last Updated: 2016-04-18

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

PHASE2/PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-29

Brief Summary

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This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).

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Detailed Description

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Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure.

Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.

Conditions

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Pulmonary Arterial Hypertension

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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Udenafil

Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil 50mg tablet

Interventions

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Udenafil

Udenafil 50mg tablet

Intervention Type DRUG

Other Intervention Names

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Zydena

Eligibility Criteria

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Inclusion Criteria

* Patients who completed the initial study(DA8159\_PAH\_II), 12-week, double-blind, placebo-controlled trial

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duk-Kyung Kim, M.D., Ph.D.

Role: STUDY_CHAIR

Samsung Medical Center

Sung-A Jang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Jun-Bin Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Hyung-Kwan Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Hyuk-Jae Jang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Hae-Ok Jung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Jung-Hyun Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Jae-Seung Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Kye-Hun Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Jin-Ok Jeong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Sang-Yeub Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Samsung Medical Center

Seoul, Gangnam-Gu, Irwon-Dong 50, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA8159_PAH_EX

Identifier Type: -

Identifier Source: org_study_id

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