Status:
COMPLETED
Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Calcific Aortic Valve Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04055883
Start Date
August 26 2019
End Date
February 1 2023
Last Update
March 3 2023
Active Locations (10)
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1
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, South Korea, 13620
2
Chonnam National University Hospital
Gwangju, Donggu, South Korea, 61469
3
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea, 06273
4
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351