Calcific Aortic Valve DiseasePhase 2DIP-CAVDNCT04055883
Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD
A Phase 2 study testing DA-1229 in people with Calcific Aortic Valve Disease, run by Dong-A ST Co., Ltd. at 10 sites in South Korea.
Trial summary
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Calcific Aortic Valve Disease
- What is being tested?
- DA-1229
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 26 Aug 2019to 1 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Kyeongpook National University Hospital
Daegu, Jung-gu, 41944
Chungnam National University Hospital
Daejeon, Jung-gu, 35015
Chonnam National University Hospital
Gwangju, Donggu, 61469
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, 13620
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06273
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Severance
Seoul, Seodaemun-gu, 03722
Asan Medical Center
Seoul, Songpa-gu, 05505
Pusan National University Yangsan Hospital
Yangsan, Mulgeum-eup, 50612
About this study
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
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
- Conditions
- Calcific Aortic Valve Disease
- Being tested
- DA-1229
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1229Drug
All participants are administered one tablet per day for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| DA-1229 5mg | Experimental | Oral administration of DA-1229 5mg tablet once a day Receives: Drug: DA-1229 |
| DA-1229 10mg | Experimental | Oral administration of DA-1229 10mg tablet once a day Receives: Drug: DA-1229 |
| DA-1229 Placebo | Placebo comparator | Oral administration of DA-1229 Placebo tablet once a day Receives: Drug: DA-1229 |
What is being measured
The primary outcome is the main question the study is designed to answer.
aortic valve calcium volume change
aortic valve calcium volume change compared to baseline(mm^3)
Measured: 96 weeks
Secondary outcomes (3)
aortic valve calcium volume change
aortic valve calcium volume change compared to baseline(mm^3)
Measured: 48 weeks
aortic valve calcium score change
aortic valve calcium score change compared to baseline(AU)
Measured: 48 weeks, 96 weeks
aortic valve calcium volume change percent
aortic valve calcium volume change percent compared to baseline(%)
Measured: 48 weeks, 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start26 Aug 2019
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcific Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055883
- Sponsor's protocol ID
- DA1229_CAVD_II
- Acronym
- DIP-CAVD
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39260927
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04055883
- Acronym / sponsor ID
- DIP-CAVD / DA1229_CAVD_II
- Conditions
- Calcific Aortic Valve Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-1229 5mg | Experimental | Drug: DA-1229Oral administration of DA-1229 5mg tablet once a day |
| DA-1229 10mg | Experimental | Drug: DA-1229Oral administration of DA-1229 10mg tablet once a day |
| DA-1229 Placebo | Placebo comparator | Drug: DA-1229Oral administration of DA-1229 Placebo tablet once a day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-1229All participants are administered one tablet per day for 96 weeks | Drug | DA-1229 10mg, DA-1229 5mg, DA-1229 Placebo |
Primary outcome
aortic valve calcium volume change
Time frame: 96 weeks
aortic valve calcium volume change compared to baseline(mm^3)
3 secondary outcomes
aortic valve calcium volume change
Time frame: 48 weeks
aortic valve calcium score change
Time frame: 48 weeks, 96 weeks
aortic valve calcium volume change percent
Time frame: 48 weeks, 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 39260927Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-1229 in people with Calcific Aortic Valve Disease, run by Dong-A ST Co., Ltd. at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aortic valve calcium volume change (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.