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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04055883
Collaborator
(none)
225
Enrollment
10
Locations
3
Arms
40.2
Anticipated Duration (Months)
22.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Aug 26, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: DA-1229 5mg

Oral administration of DA-1229 5mg tablet once a day

Drug: DA-1229
All participants are administered one tablet per day for 96 weeks
Experimental: DA-1229 10mg

Oral administration of DA-1229 10mg tablet once a day

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

Oral administration of DA-1229 Placebo tablet once a day

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

Outcome Measures

Primary Outcome Measures

  1. aortic valve calcium volume change [96 weeks]

    aortic valve calcium volume change compared to baseline(mm^3)

Secondary Outcome Measures

  1. aortic valve calcium volume change [48 weeks]

    aortic valve calcium volume change compared to baseline(mm^3)

  2. aortic valve calcium score change [48 weeks, 96 weeks]

    aortic valve calcium score change compared to baseline(AU)

  3. aortic valve calcium volume change percent [48 weeks, 96 weeks]

    aortic valve calcium volume change percent compared to baseline(%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Bundang-gu Korea, Republic of 13620
2 Chonnam National University Hospital Gwangju Donggu Korea, Republic of 61469
3 Gangnam Severance Hospital Seoul Gangnam-gu Korea, Republic of 06273
4 Samsung Medical Center Seoul Gangnam-gu Korea, Republic of 06351
5 Seoul National University Hospital Seoul Jongno-gu Korea, Republic of 03080
6 Kyeongpook National University Hospital Daegu Jung-gu Korea, Republic of 41944
7 Chungnam National University Hospital Daejeon Jung-gu Korea, Republic of 35015
8 Pusan National University Yangsan Hospital Yangsan Mulgeum-eup Korea, Republic of 50612
9 Severance Seoul Seodaemun-gu Korea, Republic of 03722
10 Asan Medical Center Seoul Songpa-gu Korea, Republic of 05505

Sponsors and Collaborators

  • Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04055883
Other Study ID Numbers:
  • DA1229_CAVD_II
First Posted:
Aug 14, 2019
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aortic Valve Disease
Heart Defects, Congenital
Heart Valve Diseases

Study Results

No Results Posted as of Aug 24, 2021