Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.

Official Title
-----------------
A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease

Conditions
-----------------
Calcific Aortic Valve Disease

Intervention / Treatment
-----------------
* Drug: DA-1229


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Criterion : 2.0m/s ≤ peak aortic-jet velocity < 4.0m/s or aortic valve calcium score ≥300AU 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: The cause of CAVD is niether degenerative nor bicuspid aortic valve The subjects who have other aortic valve disease as other clinically significant aortic insufficiency or mitral disease The subjects who had an aortic valve operation or are expected to need aortic valve operation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-1229 5mg<br>Oral administration of DA-1229 5mg tablet once a day | Drug: DA-1229<br>* All participants are administered one tablet per day for 96 weeks<br>|
| Experimental: DA-1229 10mg<br>Oral administration of DA-1229 10mg tablet once a day | Drug: DA-1229<br>* All participants are administered one tablet per day for 96 weeks<br>|
| Placebo Comparator: DA-1229 Placebo<br>Oral administration of DA-1229 Placebo tablet once a day | Drug: DA-1229<br>* All participants are administered one tablet per day for 96 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aortic valve calcium volume change | aortic valve calcium volume change compared to baseline(mm^3) | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 48 weeks, 96 weeks | 
| aortic valve calcium volume change percent | aortic valve calcium volume change percent compared to baseline(%) | 48 weeks, 96 weeks |