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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

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