Clinical Trial Details
| Trial ID: | L5599 |
| Source ID: | NCT04521452 |
| Associated Drug: | Evogliptin |
| Title: | Randomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | CAVD |
| Interventions: | DRUG: Evogliptin |
| Outcome Measures: | Primary: Change in aortic valve calcium volume at week 96 from baseline, 96 weeks | Secondary: Change in aortic valve calcium volume at week 48 from baseline, 96 weeks|Change in aortic valve calcium score at week 48 and week 96 from baseline, 48 weeks, 96 weeks|Rate of change (%) in aortic valve calcium volume at week 48 and week 96 from baseline, 48 weeks, 96 weeks|Change in peak aortic-jet velocity at week 48 and week 96 from baseline, 48 weeks, 96 weeks|Change in aortic peak & mean pressure gradient at week 48 and week 96 from baseline, 48 weeks, 96 weeks|Change in aortic valve area at week 48 and week 96 from baseline, 48 weeks, 96 weeks|Time of major cardiovascular event, anytime during the entire follow-up of 96 weeks |
| Sponsor/Collaborators: | Sponsor: Asan Medical Center | Collaborators: REDNVIA Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 218 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION |
| Start Date: | 2020-09 |
| Completion Date: | 2024-09 |
| Results First Posted: | |
| Last Update Posted: | 2020-08-20 |
| Locations: | Asan Medical Center, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT04521452 |
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