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Completed

NCT Number: NCT04055883

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

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

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Key information

Conditions

Calcific Aortic Valve Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Bundang-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-1229

Drug

All participants are administered one tablet per day for 96 weeks

Primary outcomes

  1. aortic valve calcium volume change

    Time frame: 96 weeks

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

Secondary outcomes

  1. aortic valve calcium volume change

    Time frame: 48 weeks

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

  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(%)

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Acronym: DIP-CAVD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2019
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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