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

Study Overview
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Brief Summary
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to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

Detailed Description
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A Multi-center, Randomized, Double-blind, Placebo control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

Official Title
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A Multi-center, Randomized, Double-blind, Placebo Control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: CKD-825
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Drug: CKD-825<br>* Dosage Form: capsule Dosage: 3 types(low/medium/high dose) Frequency: QD(once daily) administration<br>* Other names: Test;Drug: Placebo oral capsule<br>* Placebo of CKD-825 Dosage Form: capsule Dosage: NA Frequency: QD administration<br>* Other names: Reference;|
| Placebo Comparator: Placebo Group<br>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 | Drug: Placebo oral capsule<br>* Placebo of CKD-825 Dosage Form: capsule Dosage: NA Frequency: QD administration<br>* Other names: Reference;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation