A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic … (NCT05143177) | Clinical Trial Compass
SuspendedPhase 2/3
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
Stopped: The study is suspended due to sponsor's business decision. There were no safety issues influencing this course of action.
United States580 participantsStarted 2022-06-27
Plain-language summary
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 2 arms in this study to which patients will be randomized in a ratio of 1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks. The 2 arms are: placebo and DA-1229 10 mg Group.
The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.
Who can participate
Age range35 Years
SexALL
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Inclusion criteria
✓. Male or female adult ≥ 35 years of age at time of screening.
✓. Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by
✓. Subject provides written informed consent prior to initiation of any study procedures.
✓. Subject understands and agrees to comply with planned study procedures.
Exclusion criteria
✕. Subject has concomitant moderate or more aortic valve regurgitation.
✕. Subject has concomitant moderate or severe mitral or tricuspid valve disease.
✕. Subjects has left ventricular ejection fraction \< 50%.
✕. Subject previous history of aortic valve surgery.
✕. Subject has NYHA class III or IV heart failure.
✕. Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal range.
What they're measuring
1
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks