Randomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD
- Sponsor
- Asan Medical Center
- Study ID
- NCT04521452
- Phase
- PHASE4
- Status
- Unknown
Conditions
- CAVD
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Evogliptin — DRUGSubjects will receive evogliptin 5 mg daily
Study Details
The purpose of this study is to assess an inhibitory effect of Evogliptin on the progression of mild-to-moderate aortic stenosis in patients with T2DM and calcific aortic stenosis.
Key Dates
- First listed
- Aug 20, 2020
- Start date
- Sep 30, 2020
- Status verified
- Aug 2020
- Primary completion
- Sep 30, 2024
- Completion
- Sep 30, 2024
Study Design
- Enrollment
- 218 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Evogliptin Groupevogliptin 5mg daily
- No Intervention: Non-evogliptin GroupDM medications except evogliptin and other DPP-4 inhibitors
Primary Outcome Measure
Change in aortic valve calcium volume at week 96 from baseline [ Time Frame: 96 weeks ]