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NCT05143177 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
A Phase 2 study of Calcific Aortic Valve Disease, sponsored by REDNVIA Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 580
- Enrollment target
- 20
- Study locations
NCT05143177 is a Phase 2 study of Calcific Aortic Valve Disease that is actively recruiting participants, run by REDNVIA Co.. The registered enrollment target is 580 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT05143177, a Phase 2 study of Calcific Aortic Valve Disease, is actively recruiting participants, sponsored by REDNVIA Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 580 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 2 arms in this study to which patients will be randomized in a ratio of 1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks. The 2 arms are: placebo and DA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Evogliptin
Study Locations (20)
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
- Beaumont Hospital, Royal Oak - Royal Oak
Florida
- Mayo Clinic, FL - Jacksonville
- Baycare Health systems - Safety Harbor
New Jersey
- Hackensack Meridian Health - Hackensack
- Rutgers- Robert Wood Johnson Medical School - New Brunswick
New York
- Ichan School of Medicine - New York
- Stony brook - Stony Brook
Ohio
- Christ Hospital - Cincinnati
- OhioHealth Research Institute - Columbus
Pennsylvania
- University of Pittsburgh Medical Center - Mechanicsburg
- Einstein Medical Center Philadelphia - Philadelphia
Arizona
- Mayo Clinic, AZ - Phoenix
California
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05143177
The ClinicalTrials.gov registry entry for NCT05143177 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is REDNVIA Co., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Calcific Aortic Valve Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05143177 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Michigan, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05143177 about?
NCT05143177 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)". This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 2 arms in this study to wh...
What is the current status of trial NCT05143177?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 580 participants. The study started on 2022-06-27. Estimated completion is 2026-12-30.
What conditions does trial NCT05143177 study?
This clinical trial studies the following conditions: Calcific Aortic Valve Disease.
What interventions are being tested in trial NCT05143177?
The interventions under investigation include: Placebo (DRUG), Evogliptin (DRUG).
Who is sponsoring clinical trial NCT05143177?
This trial is sponsored by REDNVIA Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05143177 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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