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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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