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)

Calcific Aortic Valve Disease Clinical Trial

Official title: An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 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)

Status Recruiting

Clinical Trial Summary

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 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 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Calcific Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

• NCT number: NCT05143177
• Study type: Interventional
• Source: REDNVIA Co., Ltd.
• Contact: Anand Balasubramanian, B.Pharm
• Phone: (301) 956 2531
• Email: anandb@amarexcro.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 27, 2022
• Completion date: December 30, 2026