Clinical trial NCT03950843: A Clinical Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 162
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

Detailed description: 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

Eligibility criteria: 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%)

Primary outcomes:
measure: Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
timeFrame: at week 6 after first drug administration
Secondary outcomes:
measure: Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
timeFrame: at week 2, week 4, week 6 and week 10 after first drug administration
measure: 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
timeFrame: 2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
measure: Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm
timeFrame: at week 6 and week 10 after first drug administration
measure: Change in modified EHRA score(European Heart Rhythm Association score of atrial fibrillation) compared with the baseline value
timeFrame: at week 2, week 4, week 6 and week 10 after first drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jong-ll
Study officials:
affiliation: Gachon University Gil Medical Center
name: Yaemin Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Yongseog Oh, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Hospital
name: JinBae Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung Universtiy Dongsan Medical Center
name: Seongwook Han, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University
name: Jongsung Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Yeonggeun On, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Kee-Jun Choi, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sejong General Hospital
name: Sang-Weon Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University
name: Gyo-Seung Hwang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Moon Hyoung Lee, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Dong-Gu Shin, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Nam-Ho Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Dae-Kyeong Jun, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jun Namgung, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Daehyeok Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Hyung Wook Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chugbuk National University Hospital
name: Daein Lee, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Hwan-Cheol Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University
name: Eue-Keun Choi, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Kyung Suk Lee, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Seon-a Jin, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: