NCT04055883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

August 12, 2019

Last Update Submit

March 1, 2023

Conditions

Calcific Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • aortic valve calcium volume change

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

    96 weeks

Secondary Outcomes (3)

  • aortic valve calcium volume change

    48 weeks

  • aortic valve calcium score change

    48 weeks, 96 weeks

  • aortic valve calcium volume change percent

    48 weeks, 96 weeks

Study Arms (3)

DA-1229 5mg

EXPERIMENTAL

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

Drug: DA-1229

DA-1229 10mg

EXPERIMENTAL

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

Drug: DA-1229

DA-1229 Placebo

PLACEBO COMPARATOR

Oral administration of DA-1229 Placebo tablet once a day

Drug: DA-1229

Interventions

DA-1229DRUG

All participants are administered one tablet per day for 96 weeks

DA-1229 10mgDA-1229 5mgDA-1229 Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, 13620, South Korea

Location

Chonnam National University Hospital

Gwangju, Donggu, 61469, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06273, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Kyeongpook National University Hospital

Daegu, Jung-gu, 41944, South Korea

Location

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Mulgeum-eup, 50612, South Korea

Location

Severance

Seoul, Seodaemun-gu, 03722, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (1)

  • Song JK, Lee S, Kim YJ, Kim HK, Ha JW, Choi EY, Park SW, Park SJ, Park YH, Park JH, Yang DH, Kim KH, Yang DH, Han S, Chae SY, Lee JS, Song JM, Cho GY. Effect of Evogliptin on the Progression of Aortic Valvular Calcification. J Am Coll Cardiol. 2024 Sep 17;84(12):1064-1075. doi: 10.1016/j.jacc.2024.06.037.

    PMID: 39260927DERIVED

MeSH Terms

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

August 26, 2019

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

KR(10)