Calcific Aortic Valve Disease
Conditions
Brief summary
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
Interventions
DRUGDA-1229
All participants are administered one tablet per day for 96 weeks
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aortic valve calcium volume change | 96 weeks | aortic valve calcium volume change compared to baseline(mm\^3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aortic valve calcium volume change | 48 weeks | aortic valve calcium volume change compared to baseline(mm\^3) |
| aortic valve calcium score change | 48 weeks, 96 weeks | aortic valve calcium score change compared to baseline(AU) |
| aortic valve calcium volume change percent | 48 weeks, 96 weeks | aortic valve calcium volume change percent compared to baseline(%) |
Countries
South Korea
Outcome results
None listed