Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD
- Registration Number
- NCT04055883
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-1229 Placebo DA-1229 Oral administration of DA-1229 Placebo tablet once a day DA-1229 10mg DA-1229 Oral administration of DA-1229 10mg tablet once a day DA-1229 5mg DA-1229 Oral administration of DA-1229 5mg tablet once a day
- Primary Outcome Measures
Name Time Method aortic valve calcium volume change 96 weeks aortic valve calcium volume change compared to baseline(mm\^3)
- Secondary Outcome Measures
Name Time Method 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(%)
Trial Locations
- Locations (10)
Chonnam National University Hospital
🇰🇷Gwangju, Donggu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Kyeongpook National University Hospital
🇰🇷Daegu, Jung-gu, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Bundang-gu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Jung-gu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Mulgeum-eup, Korea, Republic of
Severance
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of