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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04055883
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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
Calcific Aortic Valve Disease Drug: DA-1229 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 26, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: DA-1229 5mg Drug: DA-1229
All participants are administered one tablet per day for 96 weeks

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

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




Primary Outcome Measures :
  1. aortic valve calcium volume change [ Time Frame: 96 weeks ]
    aortic valve calcium volume change compared to baseline(mL)


Secondary Outcome Measures :
  1. aortic valve calcium volume change [ Time Frame: 48 weeks ]
    aortic valve calcium volume change compared to baseline(mL)

  2. aortic valve calcium score change [ Time Frame: 48 weeks, 96 weeks ]
    aortic valve calcium score change compared to baseline(AU)

  3. aortic valve calcium volume change percent [ Time Frame: 48 weeks, 96 weeks ]
    aortic valve calcium volume change percent compared to baseline(%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055883


Contacts
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Contact: Jae-Kwan Song, PhD 82-2-3010-3155 jksong@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 05505
Contact: Jae-Kwan Song, PhD    82-2-3010-3155    jksong@amc.seoul.kr   
Principal Investigator: Jae-Kwan Song, PhD         
Sponsors and Collaborators
Dong-A ST Co., Ltd.
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT04055883    
Other Study ID Numbers: DA1229_CAVD_II
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities