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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-825
Placebo oral capsule
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Jong-llRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
To compare experimental group with placebo group

Secondary Outcome Measures

Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
To compare experimental group with placebo group
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
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm
To compare experimental group with placebo group
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

Full Information

First Posted
April 29, 2019
Last Updated
May 13, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03950843
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CKD-825
Other Intervention Name(s)
Test
Intervention Description
Dosage Form: capsule Dosage: 3 types(low/medium/high dose) Frequency: QD(once daily) administration
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Reference
Intervention Description
Placebo of CKD-825 Dosage Form: capsule Dosage: NA Frequency: QD administration
Primary Outcome Measure Information:
Title
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
Description
To compare experimental group with placebo group
Time Frame
at week 6 after first drug administration
Secondary Outcome Measure Information:
Title
Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
Description
To compare experimental group with placebo group
Time Frame
at week 2, week 4, week 6 and week 10 after first drug administration
Title
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
Description
To compare experimental group with placebo group
Time Frame
2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
Title
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm
Description
To compare experimental group with placebo group
Time Frame
at week 6 and week 10 after first drug administration
Title
Change in modified EHRA score(European Heart Rhythm Association score of atrial fibrillation) compared with the baseline value
Description
To compare experimental group with placebo group
Time Frame
at week 2, week 4, week 6 and week 10 after first drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-ll Choi, M.D, Ph.D
Phone
+82-2-2072-4164
Email
stabler92@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-ll Choi
Phone
+82-2-2072-4164
Email
stabler92@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaemin Park, M.D, Ph.D
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongseog Oh, M.D, Ph.D
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JinBae Kim, M.D, Ph.D
Organizational Affiliation
Kyunghee University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seongwook Han, M.D, Ph.D
Organizational Affiliation
Keimyung Universtiy Dongsan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jongsung Park, M.D, Ph.D
Organizational Affiliation
Dong-A University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeonggeun On, M.D, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kee-Jun Choi, M.D, Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Weon Park, M.D, Ph.D
Organizational Affiliation
Sejong General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gyo-Seung Hwang, M.D, Ph.D
Organizational Affiliation
Ajou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moon Hyoung Lee, M.D, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Gu Shin, M.D, Ph.D
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nam-Ho Kim, M.D, Ph.D
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae-Kyeong Jun, M.D, Ph.D
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Namgung, M.D, Ph.D
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daehyeok Kim, M.D, Ph.D
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyung Wook Park, M.D, Ph.D
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daein Lee, M.D, Ph.D
Organizational Affiliation
Chugbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hwan-Cheol Park, M.D, Ph.D
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eue-Keun Choi, M.D, Ph.D
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung Suk Lee, M.D, Ph.D
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seon-a Jin, M.D, Ph.D
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jong-ll
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-ll Chio, M.D, Ph.D
Email
stabler92@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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