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

May 13, 2019 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: CKD-825
  • Dosage Form: capsule
  • Dosage: 3 types(low/medium/high dose)
  • Frequency: QD(once daily) administration
Other Names:
  • Test
Drug: Placebo oral capsule

Placebo of CKD-825

  • Dosage Form: capsule
  • Dosage: NA
  • Frequency: QD administration
Other Names:
  • Reference
PLACEBO_COMPARATOR: 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
Drug: Placebo oral capsule

Placebo of CKD-825

  • Dosage Form: capsule
  • Dosage: NA
  • Frequency: QD administration
Other Names:
  • Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
Time Frame: at week 6 after first drug administration
To compare experimental group with placebo group
at week 6 after first drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
Time Frame: at week 2, week 4, week 6 and week 10 after first drug administration
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
Time Frame: 2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
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
Time Frame: at week 6 and week 10 after first drug administration
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
Time Frame: at week 2, week 4, week 6 and week 10 after first drug administration
To compare experimental group with placebo group
at week 2, week 4, week 6 and week 10 after first drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2019

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (ACTUAL)

May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125AF18022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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