Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
1 other identifier
interventional
59
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 18, 2016
April 1, 2016
1.8 years
November 26, 2014
April 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
during 48-weeks
Secondary Outcomes (6)
6-MWD
24, 48-week
BORG dyspnea score
24, 48-week
WHO class
12, 24, 36, 48-week
Time to clinical worsening(TTCW)
during 48-weeks
NT-pro BNP
24, 48-week
- +1 more secondary outcomes
Study Arms (1)
Udenafil
EXPERIMENTALUdenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
Interventions
Eligibility Criteria
You may qualify if:
- Patients who completed the initial study(DA8159\_PAH\_II), 12-week, double-blind, placebo-controlled trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam-Gu, Irwon-Dong 50, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 1, 2014
Study Start
April 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 18, 2016
Record last verified: 2016-04