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

Recruitment & Eligibility

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%)

Study & Design

Arm && Interventions

Group	Intervention	Description
Experimental Group	Placebo oral capsule	* Patients assigned to this group are treated with 1 capsule of CKD-825 and 2 placebo capsules(the placebo of CKD-825) * The necessity of a dose titration is adjudicated every 2 weeks. * After unblinding at the end of Administration Period, only patients in experimental group are treated with 1 capsule of CKD-825 for additional 4 weeks of Extension Period.
Placebo Group	Placebo oral capsule	* Patients assigned to this group are treated with 3 placebo capsules (the placebo of CKD-825) * The necessity of a dose titration is adjudicated every 2 weeks
Experimental Group	CKD-825	* Patients assigned to this group are treated with 1 capsule of CKD-825 and 2 placebo capsules(the placebo of CKD-825) * The necessity of a dose titration is adjudicated every 2 weeks. * After unblinding at the end of Administration Period, only patients in experimental group are treated with 1 capsule of CKD-825 for additional 4 weeks of Extension Period.

Primary Outcome Measures

Name	Time	Method
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value	at week 6 after first drug administration	To compare experimental group with placebo group

Secondary Outcome Measures

Name	Time	Method
Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value	at week 2, week 4, week 6 and week 10 after first drug administration	To compare experimental group with placebo group
Percentages of patients whose resting HR on 12-lead ECG achieved below 110 bpm at week 6 and week 10 among those with resting HR ≥ 110 bpm from baseline	2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration	To compare experimental group with placebo group
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm	at week 6 and week 10 after first drug administration	To compare experimental group with placebo group
Change in modified EHRA score(European Heart Rhythm Association score of atrial fibrillation) compared with the baseline value	at week 2, week 4, week 6 and week 10 after first drug administration	To compare experimental group with placebo group

Recruitment & Eligibility