NCT03950843Unknown3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
研究概览
简要总结
to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%)
研究组 & 干预措施
Experimental Group
Experimental
- 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.
干预措施: CKD-825 (Drug)
Experimental Group
Experimental
- 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.
干预措施: Placebo oral capsule (Drug)
Placebo Group
Placebo Comparator
- 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
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
时间窗: at week 6 after first drug administration
To compare experimental group with placebo group
次要结局
- 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)
- 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)
- Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm(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(at week 2, week 4, week 6 and week 10 after first drug administration)
研究者
研究点 (1)
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