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

March 1, 2023 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Bundang-gu
      • Seongnam-si, Bundang-gu, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Donggu
      • Gwangju, Donggu, Korea, Republic of, 61469
        • Chonnam National University Hospital
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Gangnam-gu, Korea, Republic of, 06273
        • Gangnam Severance Hospital
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital
    • Jung-gu
      • Daegu, Jung-gu, Korea, Republic of, 41944
        • Kyeongpook National University Hospital
      • Daejeon, Jung-gu, Korea, Republic of, 35015
        • Chungnam National University Hospital
    • Mulgeum-eup
      • Yangsan, Mulgeum-eup, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 03722
        • Severance
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 05505
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aortic valve calcium volume change
Time Frame: 96 weeks
aortic valve calcium volume change compared to baseline(mm^3)
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aortic valve calcium volume change
Time Frame: 48 weeks
aortic valve calcium volume change compared to baseline(mm^3)
48 weeks
aortic valve calcium score change
Time Frame: 48 weeks, 96 weeks
aortic valve calcium score change compared to baseline(AU)
48 weeks, 96 weeks
aortic valve calcium volume change percent
Time Frame: 48 weeks, 96 weeks
aortic valve calcium volume change percent compared to baseline(%)
48 weeks, 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_CAVD_II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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