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This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| udenafil | Experimental |
|
|
| placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| udenafil | Drug | Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase IIa - Pulmonary vascular resistance index(PVRI) | 4 hours | |
| Phase IIb - 6-minute walk distance | 16weeks |
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Inclusion Criteria:
• Subjects aged 18 and over who have any of the following diseases
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duk-Kyung Kim, M.D., Ph.D | Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Chongno-gu, 28 Yongon-dong | 110-744 | South Korea | ||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31202506 | Derived | 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. | |
| 30808080 |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| placebo |
| Drug |
Phase IIa - placebo Phase IIb - placebo |
|
| Seoul |
| Gangnam-Gu, Irwon-Dong 50 |
| 135-710 |
| South Korea |
| Severance Hospital, Yonsei University Health System | Special City of Seoul | Seodaemungu, 250 Seonsanno | 120-752 | 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 |
| 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. |