- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02304198
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
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
-
-
Gangnam-Gu, Irwon-Dong 50
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Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of, 135-710
- Samsung Medical Center
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-
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)
|
Udenafil 50mg tablet
Other Names:
|
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
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
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension, Pulmonary
- Hypertension
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Udenafil
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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