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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2023-02-01

Brief Summary

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

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Detailed Description

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Conditions

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Calcific Aortic Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DA-1229 5mg

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

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

All participants are administered one tablet per day for 96 weeks

DA-1229 10mg

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

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

All participants are administered one tablet per day for 96 weeks

DA-1229 Placebo

Oral administration of DA-1229 Placebo tablet once a day

Group Type PLACEBO_COMPARATOR

DA-1229

Intervention Type DRUG

All participants are administered one tablet per day for 96 weeks

Interventions

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DA-1229

All participants are administered one tablet per day for 96 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No