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This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-1229 5mg | Experimental | Oral administration of DA-1229 5mg tablet once a day |
|
| DA-1229 10mg | Experimental | Oral administration of DA-1229 10mg tablet once a day |
|
| DA-1229 Placebo | Placebo Comparator | Oral administration of DA-1229 Placebo tablet once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-1229 | Drug | All participants are administered one tablet per day for 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| aortic valve calcium volume change | aortic valve calcium volume change compared to baseline(mm^3) | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| aortic valve calcium volume change | aortic valve calcium volume change compared to baseline(mm^3) | 48 weeks |
| aortic valve calcium score change | aortic valve calcium score change compared to baseline(AU) |
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Inclusion Criteria:
Adult male and female subjects of ages in the range over 19
The subjects whose echocardiography or heart CT result meets the criterion in the screening period or 4 weeks before screening visit
The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Bundang-gu | 13620 | South Korea | ||
| Chonnam National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260927 | Derived | Song JK, Lee S, Kim YJ, Kim HK, Ha JW, Choi EY, Park SW, Park SJ, Park YH, Park JH, Yang DH, Kim KH, Yang DH, Han S, Chae SY, Lee JS, Song JM, Cho GY. Effect of Evogliptin on the Progression of Aortic Valvular Calcification. J Am Coll Cardiol. 2024 Sep 17;84(12):1064-1075. doi: 10.1016/j.jacc.2024.06.037. |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
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| 48 weeks, 96 weeks |
| aortic valve calcium volume change percent | aortic valve calcium volume change percent compared to baseline(%) | 48 weeks, 96 weeks |
| Gwangju |
| Donggu |
| 61469 |
| South Korea |
| Gangnam Severance Hospital | Seoul | Gangnam-gu | 06273 | South Korea |
| Samsung Medical Center | Seoul | Gangnam-gu | 06351 | South Korea |
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
| Kyeongpook National University Hospital | Daegu | Jung-gu | 41944 | South Korea |
| Chungnam National University Hospital | Daejeon | Jung-gu | 35015 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Mulgeum-eup | 50612 | South Korea |
| Severance | Seoul | Seodaemun-gu | 03722 | South Korea |
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |