All > Aortic Stenosis

DA-1229 5mg for Calcific Aortic Valve Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MNCalcific Aortic Valve Disease+2 MoreEvogliptin - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug, DA-1229, for patients with aortic valve disease. The study will last 104 weeks, and patients will be given the drug either once a day or as a placebo. The study will have 3 phases: Screening, Treatment, and Follow-Up.

Eligible Conditions
  • Calcific Aortic Valve Disease
  • Aortic Valve Stenosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 104 weeks

104 weeks
Aortic Valve Stenosis
Time-to-major adverse cardiovascular events of cardiac death, non- fatal myocardial infarction, heart failure hospitalization and stroke
Time-to-symptom onset
at 104 weeks
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks
Week 104
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 104 as compared to baseline
Change in aortic stenosis severity as measured by dimensionless velocity using echocardiography at week 104 as compared to baseline
Change in aortic stenosis severity as measured by mean pressure gradient using echocardiography at week 104 as compared to baseline
Change in aortic stenosis severity as measured by peak transaortic velocity using echocardiography at week 104 as compared to baseline
Change in coronary artery and mitral annulus calcium score at week 104 as compared to baseline
at week 52
Aortic valve calcification as measured by Agatston AU using cardiac computed tomography (CT) at week 52
Week 52
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 52 as compared to baseline
Change in aortic stenosis severity as measured by dimensionless velocity using echocardiography at week 52 as compared to baseline
Change in aortic stenosis severity as measured by mean pressure gradient using echocardiography at week 52 as compared to baseline
Aortic Valve Stenosis
Change in coronary artery and mitral annulus calcium score at week 52 as compared to baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Colchicine 0.6 mg
2
Transseptal ViMAC
1
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Trial Design

3 Treatment Groups

DA-1229 5mg
1 of 3
DA-1229 10 mg
1 of 3
Placebo
1 of 3

Active Control

Non-Treatment Group

867 Total Participants · 3 Treatment Groups

Primary Treatment: DA-1229 5mg · Has Placebo Group · Phase 2 & 3

DA-1229 5mg
Drug
ActiveComparator Group · 1 Intervention: Evogliptin · Intervention Types: Drug
DA-1229 10 mg
Drug
ActiveComparator Group · 1 Intervention: Evogliptin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 104 weeks

Who is running the clinical trial?

REDNVIA Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
218 Total Patients Enrolled
Jae K Oh, MDPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

To your knowledge, are there other similar trials underway?

"As of now, 4 trials for DA-1229 10 mg are underway in 11 cities within 2 nations. The first ever trial for DA-1229 10 mg was in 2019. That year, the study - which was sponsored by Dong-A ST Co., Ltd. - had 225 individuals taking part. It completed its Phase 2 drug approval. In the two years since 2019, a total of 18,281 trials have been completed." - Anonymous Online Contributor

Unverified Answer

Are there precedents for giving DA-1229 10 mg to patients?

"As of now, 4 different clinical trials are studying the effects of DA-1229 10 mg. 1 of these trials is currently in Phase 3. Most of the research is taking place in Seoul, Gangwondo; however, there are a total of 19 sites running DA-1229 10 mg trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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