Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD (DIP-CAVD)

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Calcific Aortic Valve Disease

Treatments: Drug: DA-1229

Study type: Interventional

Funder types: Industry

Identifiers

NCT04055883

DA1229_CAVD_II

Details and patient eligibility

About

This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.

Enrollment: 228 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 3 patient groups, including a placebo group

DA-1229 5mg

Experimental group

Description:

Oral administration of DA-1229 5mg tablet once a day

Treatment:

Drug: DA-1229

DA-1229 10mg

Experimental group

Description:

Oral administration of DA-1229 10mg tablet once a day

Treatment:

Drug: DA-1229

DA-1229 Placebo

Placebo Comparator group

Description:

Oral administration of DA-1229 Placebo tablet once a day

Treatment:

Drug: DA-1229