A Clinical Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

Inclusion Criteria:

• Outpatients aged ≥ 19 years with persistent or permanent Atrial Fibrillation

• Patients with modified EHRA(The European Heart Rhythm Association score of atrial fibrillation) score ≥ 2a

• Patients with resting HR ≥ 80 beats per minute(bpm)

• Patients with 24-h mHR ≥ 80 bpm on Holter ECG

Exclusion Criteria:

• Treatment with antiarrhythmics within 2 weeks(Those who had washout period can be included)

• Pacemaker or implantable cardioverter defibrillator

• Catheter ablation for atrial fibrillation within 12 weeks before first investigational product(IP) administration

• Treatment for heart failure (New York Heart Association functional class 4)

• Myocardial infarction or unstable angina pectoris within 12 weeks before first IP administration

• Wolff-Parkinson-White syndrome

• Hepatic or renal disorder

• Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg

• Uncontrolled Diabetes(HbA1c > 9%)