Back to resultsClinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
Exclusion Criteria:
-
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Udenafil
Arm Description
Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
Outcomes
Primary Outcome Measures
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
Secondary Outcome Measures
6-MWD
BORG dyspnea score
WHO class
Time to clinical worsening(TTCW)
NT-pro BNP
Echocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02304198
Brief Title
Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
Official Title
A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Udenafil
Arm Type
Experimental
Arm Description
Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
Intervention Type
Drug
Intervention Name(s)
Udenafil
Other Intervention Name(s)
Zydena
Intervention Description
Udenafil 50mg tablet
Primary Outcome Measure Information:
Title
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
Description
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
Time Frame
during 48-weeks
Secondary Outcome Measure Information:
Title
6-MWD
Time Frame
24, 48-week
Title
BORG dyspnea score
Time Frame
24, 48-week
Title
WHO class
Time Frame
12, 24, 36, 48-week
Title
Time to clinical worsening(TTCW)
Time Frame
during 48-weeks
Title
NT-pro BNP
Time Frame
24, 48-week
Title
Echocardiography
Time Frame
48-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-Kyung Kim, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sung-A Jang, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun-Bin Park, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyuk-Jae Jang, M.D., Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hae-Ok Jung, M.D., Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung-Hyun Choi, M.D., Ph.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Seung Lee, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kye-Hun Kim, M.D., Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-Ok Jeong, M.D., Ph.D.
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Yeub Lee, M.D., Ph.D.
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu, Irwon-Dong 50
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
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