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to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
|
|
| Placebo Group | Placebo Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-825 | Drug |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong-ll Choi, M.D, Ph.D | Contact | +82-2-2072-4164 | stabler92@gmail.com | |
| Jong-ll Choi | Contact | +82-2-2072-4164 | stabler92@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaemin Park, M.D, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
| Yongseog Oh, M.D, Ph.D | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jong-ll | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Placebo oral capsule | Drug | Placebo of CKD-825
|
|
|
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 |
| JinBae Kim, M.D, Ph.D |
| Kyunghee University Hospital |
| Principal Investigator |
| Seongwook Han, M.D, Ph.D | Keimyung Universtiy Dongsan Medical Center | Principal Investigator |
| Jongsung Park, M.D, Ph.D | Dong-A University | Principal Investigator |
| Yeonggeun On, M.D, Ph.D | Samsung Medical Center | Principal Investigator |
| Kee-Jun Choi, M.D, Ph.D | Asan Medical Center | Principal Investigator |
| Sang-Weon Park, M.D, Ph.D | Sejong General Hospital | Principal Investigator |
| Gyo-Seung Hwang, M.D, Ph.D | Ajou University | Principal Investigator |
| Moon Hyoung Lee, M.D, Ph.D | Severance Hospital | Principal Investigator |
| Dong-Gu Shin, M.D, Ph.D | Dong-A University Hospital | Principal Investigator |
| Nam-Ho Kim, M.D, Ph.D | Wonkwang University Hospital | Principal Investigator |
| Dae-Kyeong Jun, M.D, Ph.D | Inje University | Principal Investigator |
| Jun Namgung, M.D, Ph.D | Inje University | Principal Investigator |
| Daehyeok Kim, M.D, Ph.D | Inha University Hospital | Principal Investigator |
| Hyung Wook Park, M.D, Ph.D | Chonnam National University Hospital | Principal Investigator |
| Daein Lee, M.D, Ph.D | Chugbuk National University Hospital | Principal Investigator |
| Hwan-Cheol Park, M.D, Ph.D | Hanyang University | Principal Investigator |
| Eue-Keun Choi, M.D, Ph.D | Seoul National University | Principal Investigator |
| Kyung Suk Lee, M.D, Ph.D | Chonbuk National University Hospital | Principal Investigator |
| Seon-a Jin, M.D, Ph.D | Chungnam National University Hospital | Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |