An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 2 Arm 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)
Who is this study for? Patients with calcific aortic valve disease with mild to moderate aortic stenosis
What treatments are being studied? Evogliptin
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:
• Male or female adult ≥ 35 years of age at time of screening.
• Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by
‣ Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on TTE within 2 weeks prior to randomization and,
⁃ Cardiac Compute Tomography (CT) test results: aortic valve calcium score (AVCS) ≥ 200 AU at baseline cardiac CT within 4 weeks prior to randomization
• Subject provides written informed consent prior to initiation of any study procedures.
• Subject understands and agrees to comply with planned study procedures.
Locations
United States
Arizona
Mayo Clinic, AZ
RECRUITING
Phoenix
California
University of Southern California
RECRUITING
Los Angeles
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Mayo Clinic, FL
RECRUITING
Jacksonville
Baycare Health systems
RECRUITING
Safety Harbor
Georgia
Northside Hospital
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Beaumont Hospital, Royal Oak
RECRUITING
Royal Oak
Minnesota
Mayo Clinic
RECRUITING
Rochester
New Jersey
Hackensack Meridian Health
RECRUITING
Hackensack
Rutgers- Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
Ichan School of Medicine
RECRUITING
New York
Stony brook
RECRUITING
Stony Brook
Ohio
Christ Hospital
RECRUITING
Cincinnati
OhioHealth Research Institute
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Mechanicsburg
Einstein Medical Center Philadelphia
RECRUITING
Philadelphia
Texas
Texas Heart Institute
RECRUITING
Houston
Virginia
Inova Health Care Services
RECRUITING
Falls Church
Vermont
The University of Vermont Medical Center
RECRUITING
Burlington
Wisconsin
Aurora Research Institute
RECRUITING
Milwaukee
Other Locations
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval