Pulmonary Arterial HypertensionPhase 2/3NCT02304198
Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
A Phase 2/3 study testing Udenafil in people with Pulmonary Arterial Hypertension, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Feb 2016
- Phase
- Phase 2/3
- 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
- Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Gangnam-Gu, Irwon-Dong 50, 135-710
About this study
Official title: 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).
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Udenafil
- 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
Also called Zydena
Udenafil 50mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Udenafil | Experimental | Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks) Receives: Drug: Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
Measured: during 48-weeks
Secondary outcomes (6)
6-MWD
Measured: 24, 48-week
BORG dyspnea score
Measured: 24, 48-week
WHO class
Measured: 12, 24, 36, 48-week
Time to clinical worsening(TTCW)
Measured: during 48-weeks
NT-pro BNP
Measured: 24, 48-week
Echocardiography
Measured: 48-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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., Study chair, Samsung Medical CenterSung-A Jang, M.D., Ph.D., Principal investigator, Samsung Medical CenterJun-Bin Park, M.D., Ph.D., Principal investigator, Seoul National University HospitalHyung-Kwan Kim, M.D., Ph.D., Principal investigator, Seoul National University HospitalHyuk-Jae Jang, M.D., Ph.D., Principal investigator, Severance HospitalHae-Ok Jung, M.D., Ph.D., Principal investigator, Seoul St. Mary's HospitalJung-Hyun Choi, M.D., Ph.D., Principal investigator, Pusan National University HospitalJae-Seung Lee, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304198
- Sponsor's protocol ID
- DA8159_PAH_EX
- Status last verified
- Apr 2016
- First submitted
- 26 Nov 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
- ClinicalTrials.gov ID
- NCT02304198
- Acronym / sponsor ID
- DA8159_PAH_EX
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Dec 2014 (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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Udenafil | Experimental | Drug: UdenafilUdenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| UdenafilAlso: ZydenaUdenafil 50mg tablet | Drug | Udenafil |
Primary outcome
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
6 secondary outcomes
6-MWD
Time frame: 24, 48-week
BORG dyspnea score
Time frame: 24, 48-week
WHO class
Time frame: 12, 24, 36, 48-week
Time to clinical worsening(TTCW)
Time frame: during 48-weeks
NT-pro BNP
Time frame: 24, 48-week
Echocardiography
Time frame: 48-week
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.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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Pulmonary Arterial Hypertension PAH
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. 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Udenafil in people with Pulmonary Arterial Hypertension, run by Dong-A ST Co., Ltd. at 1 site 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 1 inclusion and 1 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc) (time frame: during 48-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.