CClinicalTrials.gg
Sign In
CompletedNCT01553721Updated Apr 18, 2016

Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

A Phase 2 interventional study of udenafil and placebo in Pulmonary Arterial Hypertension, sponsored by Dong-A ST Co., Ltd.. Completed at 9 sites 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, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).

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 63 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

  • Subjects aged 18 and over who have any of the following diseases
  • primary Pulmonary Arterial Hypertension
  • secondary Pulmonary Arterial Hypertension caused by connective tissue disease
  • [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion criteria

Exclusion Criteria:

  • Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
  • BMI(Body Mass Index) \< 18.5kg/m2
  • Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg)
  • Creatinine clearance ≤ 30mL/min
  • History of non-arteritic anterior ischemic optic neuropathy(NAION)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    udenafil

    1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil

    Drug: udenafil

  • Placebo comparator
    placebo

    1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo

    Drug: placebo

Interventions

  • Drugudenafil

    Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)

  • Drugplacebo

    Phase IIa - placebo Phase IIb - placebo

06

What researchers measure

Primary outcomes

  1. Phase IIa - Pulmonary vascular resistance index(PVRI)

    Time frame: 4 hours

  2. Phase IIb - 6-minute walk distance

    Time frame: 16weeks

07

Study locations

9 sites
  • Seoul National University Hospital
    Seoul, Chongno-gu, 28 Yongon-dong 110-744, Korea, Republic of
  • Samsung Medical Center
    Seoul, Gangnam-Gu, Irwon-Dong 50 135-710, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Special City of Seoul, Seodaemungu, 250 Seonsanno 120-752, Korea, Republic of
  • Chungbook national University Hospital
    Chung-ju, Korea, Republic of
  • Chungnam National University Hospital
    Daejeon, Korea, Republic of
  • Chonnam National University Hospital
    Gwang-ju, Korea, Republic of
  • Pusan national University Hospital
    Pusan, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • The catholic univ. of korea Seoul ST. MARY's hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Chang HJ, Song S, Chang SA, Kim HK, Jung HO, Choi JH, Lee JS, Kim KH, Jeong JO, Lee JH, Kim DK. Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial. Clin Ther. 2019 Aug;41(8):1499-1507. doi: 10.1016/j.clinthera.2019.05.006. Epub 2019 Jun 13. PubMed 31202506 ↗
  • Chang SA, Kim HK, Chang HJ, Kim DK. Acute Hemodynamic Changes after Single Administration of Udenafil in Pulmonary Arterial Hypertension: a Phase IIa Study. Korean Circ J. 2019 Apr;49(4):353-360. doi: 10.4070/kcj.2018.0281. Epub 2018 Dec 10. PubMed 30808080 ↗
09

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 ↗
10

Registry details

Key details

Study ID
NCT01553721
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Mar 14, 2012
Start date
Aug 2011
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 18, 2016

Study contacts

Duk-Kyung Kim, M.D., Ph.D
principal investigator · Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea

Oversight

Data monitoring committee
Yes
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Arterial Hypertension→

Other studies from this sponsor

Dong-A ST Co., Ltd.

Start the discussion