Pulmonary Arterial HypertensionPhase 2NCT01553721
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
A Phase 2 study testing udenafil in people with Pulmonary Arterial Hypertension, run by Dong-A ST Co., Ltd. at 9 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- udenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Aug 2011to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Chungbook national University Hospital
Chungju
Chungnam National University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Pusan national University Hospital
Pusan
Seoul National University Hospital
Seoul, Chongno-gu, 28 Yongon-dong, 110-744
Samsung Medical Center
Seoul, Gangnam-Gu, Irwon-Dong 50, 135-710
Asan Medical Center
Seoul
The catholic univ. of korea Seoul ST. MARY's hospital
Seoul
Severance Hospital, Yonsei University Health System
Special City of Seoul, Seodaemungu, 250 Seonsanno, 120-752
About this study
Official title: A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
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).
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- udenafil, placebo
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
udenafilDrug
Phase IIa - Udenafil Dose 1, Dose 2(Single dose)
Phase IIb - Udenafil(BID)
placeboDrug
Phase IIa - placebo Phase IIb - placebo
| Study group | Role | What they receive |
|---|---|---|
| udenafil | Experimental | 1. Phase IIa Experimental : Udenafil Dose 1, Dose 2
2. Phase IIb Experimental : Udenafil Receives: Drug: udenafil |
| placebo | Placebo comparator | 1. Phase IIa Placebo Comparator : Placebo
2. Phase IIb Placebo Comparator : Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase IIa - Pulmonary vascular resistance index(PVRI)
Measured: 4 hours
Phase IIb - 6-minute walk distance
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duk-Kyung Kim, M.D., Ph.D, Principal investigator, Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553721
- Sponsor's protocol ID
- DA8159_PAH_II
- Status last verified
- Apr 2016
- First submitted
- 1 Jan 2012
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 31202506Chang 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
- ClinicalTrials.gov ID
- NCT01553721
- Acronym / sponsor ID
- DA8159_PAH_II
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| udenafil | Experimental | Drug: udenafil1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil |
| placebo | Placebo comparator | Drug: placebo1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| udenafilPhase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID) | Drug | udenafil |
| placeboPhase IIa - placebo Phase IIb - placebo | Drug | placebo |
Primary outcome
Phase IIa - Pulmonary vascular resistance index(PVRI)
Time frame: 4 hours
Phase IIb - 6-minute walk distance
Time frame: 16weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Derived from this study: PubMed 31202506Chang 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.
- Derived from this study: PubMed 30808080Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk-Kyung Kim, M.D., Ph.D principal investigator
Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing udenafil in people with Pulmonary Arterial Hypertension, run by Dong-A ST Co., Ltd. at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase IIa - Pulmonary vascular resistance index(PVRI) (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.