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

April 15, 2016 updated by: Dong-A ST Co., Ltd.

A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-Gu, Irwon-Dong 50
      • Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Udenafil
Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
Drug: Udenafil
Udenafil 50mg tablet
Other Names:
  • Zydena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
Time Frame: during 48-weeks
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
during 48-weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
6-MWD
Time Frame: 24, 48-week
24, 48-week
BORG dyspnea score
Time Frame: 24, 48-week
24, 48-week
WHO class
Time Frame: 12, 24, 36, 48-week
12, 24, 36, 48-week
Time to clinical worsening(TTCW)
Time Frame: during 48-weeks
during 48-weeks
NT-pro BNP
Time Frame: 24, 48-week
24, 48-week
Echocardiography
Time Frame: 48-week
48-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Study Chair: Duk-Kyung Kim, M.D., Ph.D., Samsung Medical Center
  • Principal Investigator: Sung-A Jang, M.D., Ph.D., Samsung Medical Center
  • Principal Investigator: Jun-Bin Park, M.D., Ph.D., Seoul National University Hospital
  • Principal Investigator: Hyung-Kwan Kim, M.D., Ph.D., Seoul National University Hospital
  • Principal Investigator: Hyuk-Jae Jang, M.D., Ph.D., Severance Hospital
  • Principal Investigator: Hae-Ok Jung, M.D., Ph.D., Seoul St. Mary'S Hospital
  • Principal Investigator: Jung-Hyun Choi, M.D., Ph.D., Pusan National University Hospital
  • Principal Investigator: Jae-Seung Lee, M.D., Ph.D., Asan Medical Center
  • Principal Investigator: Kye-Hun Kim, M.D., Ph.D., Chonnam National University Hospital
  • Principal Investigator: Jin-Ok Jeong, M.D., Ph.D., Chungnam National University Hospital
  • Principal Investigator: Sang-Yeub Lee, M.D., Ph.D., Chungbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (ESTIMATE)

December 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_PAH_EX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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