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

Primary Purpose

Calcific Aortic Valve Disease

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-1229
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Calcific Aortic Valve Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Chonnam National University Hospital
  • Gangnam Severance Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Kyeongpook National University Hospital
  • Chungnam National University Hospital
  • Pusan National University Yangsan Hospital
  • Severance
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DA-1229 5mg

DA-1229 10mg

DA-1229 Placebo

Arm Description

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

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

Oral administration of DA-1229 Placebo tablet once a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

aortic valve calcium volume change
aortic valve calcium volume change compared to baseline(mm^3)
aortic valve calcium score change
aortic valve calcium score change compared to baseline(AU)
aortic valve calcium volume change percent
aortic valve calcium volume change percent compared to baseline(%)

Full Information

First Posted
August 12, 2019
Last Updated
March 1, 2023
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04055883
Brief Title
Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Aortic Valve Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DA-1229 5mg
Arm Type
Experimental
Arm Description
Oral administration of DA-1229 5mg tablet once a day
Arm Title
DA-1229 10mg
Arm Type
Experimental
Arm Description
Oral administration of DA-1229 10mg tablet once a day
Arm Title
DA-1229 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration of DA-1229 Placebo tablet once a day
Intervention Type
Drug
Intervention Name(s)
DA-1229
Intervention Description
All participants are administered one tablet per day for 96 weeks
Primary Outcome Measure Information:
Title
aortic valve calcium volume change
Description
aortic valve calcium volume change compared to baseline(mm^3)
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
aortic valve calcium volume change
Description
aortic valve calcium volume change compared to baseline(mm^3)
Time Frame
48 weeks
Title
aortic valve calcium score change
Description
aortic valve calcium score change compared to baseline(AU)
Time Frame
48 weeks, 96 weeks
Title
aortic valve calcium volume change percent
Description
aortic valve calcium volume change percent compared to baseline(%)
Time Frame
48 weeks, 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Bundang-gu
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Donggu
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kyeongpook National University Hospital
City
Daegu
State/Province
Jung-gu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Mulgeum-eup
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Severance
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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