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

Calcific Aortic Valve Disease Clinical Trial

— DIP-CAVD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055883
• Other study ID #: DA1229_CAVD_II
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Calcific Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Drug:
• DA-1229
All participants are administered one tablet per day for 96 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kyeongpook National University Hospital	Daegu	Jung-gu
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu
Korea, Republic of	Chonnam National University Hospital	Gwangju	Donggu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Bundang-gu
Korea, Republic of	Asan Medical Center	Seoul	Songpa-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 Hospital	Seoul	Jongno-gu
Korea, Republic of	Severance	Seoul	Seodaemun-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Mulgeum-eup

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aortic valve calcium volume change	aortic valve calcium volume change compared to baseline(mm^3)	96 weeks
Secondary	aortic valve calcium volume change	aortic valve calcium volume change compared to baseline(mm^3)	48 weeks
Secondary	aortic valve calcium score change	aortic valve calcium score change compared to baseline(AU)	48 weeks, 96 weeks
Secondary	aortic valve calcium volume change percent	aortic valve calcium volume change percent compared to baseline(%)	48 weeks, 96 weeks