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CompletedNCT02304198Updated Apr 18, 2016

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

A Phase 2/3 interventional study of Udenafil in Pulmonary Arterial Hypertension, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-18.

Sponsored by Dong-A ST Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 59 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Udenafil

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

    Drug: Udenafil

Interventions

  • DrugUdenafil

    Udenafil 50mg tablet

    Also known as: Zydena

06

What researchers measure

Primary outcomes

  1. Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)

    Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc

    Time frame: during 48-weeks

Secondary outcomes

  1. 6-MWD

    Time frame: 24, 48-week

  2. BORG dyspnea score

    Time frame: 24, 48-week

  3. WHO class

    Time frame: 12, 24, 36, 48-week

  4. Time to clinical worsening(TTCW)

    Time frame: during 48-weeks

  5. NT-pro BNP

    Time frame: 24, 48-week

  6. Echocardiography

    Time frame: 48-week

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Gangnam-Gu, Irwon-Dong 50 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02304198
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Dec 1, 2014
Start date
Apr 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 18, 2016

Study contacts

Duk-Kyung Kim, M.D., Ph.D.
study chair · Samsung Medical Center
Sung-A Jang, M.D., Ph.D.
principal investigator · Samsung Medical Center
Jun-Bin Park, M.D., Ph.D.
principal investigator · Seoul National University Hospital
Hyung-Kwan Kim, M.D., Ph.D.
principal investigator · Seoul National University Hospital
Hyuk-Jae Jang, M.D., Ph.D.
principal investigator · Severance Hospital
Hae-Ok Jung, M.D., Ph.D.
principal investigator · Seoul St. Mary's Hospital
Jung-Hyun Choi, M.D., Ph.D.
principal investigator · Pusan National University Hospital
Jae-Seung Lee, M.D., Ph.D.
principal investigator · Asan Medical Center
Kye-Hun Kim, M.D., Ph.D.
principal investigator · Chonnam National University Hospital
Jin-Ok Jeong, M.D., Ph.D.
principal investigator · Chungnam National University Hospital
Sang-Yeub Lee, M.D., Ph.D.
principal investigator · Chungbuk National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Dong-A ST Co., Ltd.

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