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

NCT03950843 | Unknown Phase 3

• 1 other identifier: 125AF18022
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value

  To compare experimental group with placebo group

  at week 6 after first drug administration

Secondary Outcomes (4)

• Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value

  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

  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

  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

  at week 2, week 4, week 6 and week 10 after first drug administration

Study Arms (2)

Experimental Group

EXPERIMENTAL

* 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; Drug: Placebo oral capsule

Placebo Group

PLACEBO COMPARATOR

* 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

Interventions

CKD-825 DRUG

* Dosage Form: capsule * Dosage: 3 types(low/medium/high dose) * Frequency: QD(once daily) administration

Also known as: Test

Experimental Group

Placebo oral capsule DRUG

Placebo of CKD-825 * Dosage Form: capsule * Dosage: NA * Frequency: QD administration

Also known as: Reference

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Jong-ll

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-ll Choi, M.D, Ph.D

CONTACT

+82-2-2072-4164; stabler92@gmail.com

Jong-ll Choi

CONTACT

+82-2-2072-4164; stabler92@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 15, 2019
• Study Start: April 23, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)