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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02304198 |
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Date of registration:
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26/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
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Scientific title:
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A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02304198 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sang-Yeub Lee, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chungbuk National University Hospital |
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Name:
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Hyuk-Jae Jang, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Severance Hospital |
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Name:
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Jun-Bin Park, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Name:
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Sung-A Jang, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center |
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Name:
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Hyung-Kwan Kim, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Name:
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Jae-Seung Lee, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Name:
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Duk-Kyung Kim, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center |
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Name:
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Jung-Hyun Choi, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Hospital |
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Name:
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Hae-Ok Jung, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul St. Mary's Hospital |
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Name:
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Kye-Hun Kim, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chonnam National University Hospital |
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Name:
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Jin-Ok Jeong, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chungnam National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind,
placebo-controlled trial
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Udenafil
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Primary Outcome(s)
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Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
[Time Frame: during 48-weeks]
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Secondary Outcome(s)
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Time to clinical worsening(TTCW)
[Time Frame: during 48-weeks]
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Echocardiography
[Time Frame: 48-week]
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BORG dyspnea score
[Time Frame: 24, 48-week]
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NT-pro BNP
[Time Frame: 24, 48-week]
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6-MWD
[Time Frame: 24, 48-week]
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WHO class
[Time Frame: 12, 24, 36, 48-week]
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Secondary ID(s)
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DA8159_PAH_EX
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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