Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
NCT ID: NCT01553721
Last Updated: 2016-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2011-08-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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udenafil
1. Phase IIa Experimental : Udenafil Dose 1, Dose 2
2. Phase IIb Experimental : Udenafil
udenafil
Phase IIa - Udenafil Dose 1, Dose 2(Single dose)
Phase IIb - Udenafil(BID)
placebo
1. Phase IIa Placebo Comparator : Placebo
2. Phase IIb Placebo Comparator : Placebo
placebo
Phase IIa - placebo Phase IIb - placebo
Interventions
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udenafil
Phase IIa - Udenafil Dose 1, Dose 2(Single dose)
Phase IIb - Udenafil(BID)
placebo
Phase IIa - placebo Phase IIb - placebo
Eligibility Criteria
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Inclusion Criteria
* primary Pulmonary Arterial Hypertension
* secondary Pulmonary Arterial Hypertension caused by connective tissue disease
* \[Phase IIb\] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)
* BMI(Body Mass Index) \< 18.5kg/m2
* Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>170/100mmHg)
* Creatinine clearance ≤ 30mL/min
* History of non-arteritic anterior ischemic optic neuropathy(NAION)
18 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Duk-Kyung Kim, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
Locations
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Seoul National University Hospital
Seoul, Chongno-gu, 28 Yongon-dong, South Korea
Samsung Medical Center
Seoul, Gangnam-Gu, Irwon-Dong 50, South Korea
Severance Hospital, Yonsei University Health System
Special City of Seoul, Seodaemungu, 250 Seonsanno, South Korea
Chungbook national University Hospital
Chungju, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Pusan national University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
The catholic univ. of korea Seoul ST. MARY's hospital
Seoul, , South Korea
Countries
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References
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Chang HJ, Song S, Chang SA, Kim HK, Jung HO, Choi JH, Lee JS, Kim KH, Jeong JO, Lee JH, Kim DK. Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial. Clin Ther. 2019 Aug;41(8):1499-1507. doi: 10.1016/j.clinthera.2019.05.006. Epub 2019 Jun 13.
Chang SA, Kim HK, Chang HJ, Kim DK. Acute Hemodynamic Changes after Single Administration of Udenafil in Pulmonary Arterial Hypertension: a Phase IIa Study. Korean Circ J. 2019 Apr;49(4):353-360. doi: 10.4070/kcj.2018.0281. Epub 2018 Dec 10.
Other Identifiers
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DA8159_PAH_II
Identifier Type: -
Identifier Source: org_study_id
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