A Clinical Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
NCT ID: NCT03950843
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
162 participants
INTERVENTIONAL
2019-04-23
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Group
* 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.
CKD-825
* Dosage Form: capsule
* Dosage: 3 types(low/medium/high dose)
* Frequency: QD(once daily) administration
Placebo oral capsule
Placebo of CKD-825
* Dosage Form: capsule
* Dosage: NA
* Frequency: QD administration
Placebo Group
* 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
Placebo oral capsule
Placebo of CKD-825
* Dosage Form: capsule
* Dosage: NA
* Frequency: QD administration
Interventions
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CKD-825
* Dosage Form: capsule
* Dosage: 3 types(low/medium/high dose)
* Frequency: QD(once daily) administration
Placebo oral capsule
Placebo of CKD-825
* Dosage Form: capsule
* Dosage: NA
* Frequency: QD administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%)
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Yaemin Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
Yongseog Oh, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
JinBae Kim, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Hospital
Seongwook Han, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Keimyung Universtiy Dongsan Medical Center
Jongsung Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Dong-A University
Yeonggeun On, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Kee-Jun Choi, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Sang-Weon Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sejong General Hospital
Gyo-Seung Hwang, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ajou University
Moon Hyoung Lee, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Dong-Gu Shin, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Nam-Ho Kim, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wonkwang University Hospital
Dae-Kyeong Jun, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Inje University
Jun Namgung, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Inje University
Daehyeok Kim, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Hyung Wook Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Daein Lee, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chugbuk National University Hospital
Hwan-Cheol Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Eue-Keun Choi, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University
Kyung Suk Lee, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Seon-a Jin, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University Hospital
Locations
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Jong-ll
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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125AF18022
Identifier Type: -
Identifier Source: org_study_id
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