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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950843
• Other study ID #: 125AF18022
• Status: Recruiting
• Phase: Phase 3
• Start date: April 23, 2019
• Est. completion date: December 2021

Study information

• Verified date: May 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: Jong-ll Choi, M.D, Ph.D
• Phone: +82-2-2072-4164
• Email: stabler92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• CKD-825
Dosage Form: capsule Dosage: 3 types(low/medium/high dose) Frequency: QD(once daily) administration
• Placebo oral capsule
Placebo of CKD-825 Dosage Form: capsule Dosage: NA Frequency: QD administration

Locations

Country	Name	City	State
Korea, Republic of	Jong-ll	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value	To compare experimental group with placebo group	at week 2, week 4, week 6 and week 10 after first drug administration
Secondary	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	2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
Secondary	Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm	To compare experimental group with placebo group	at week 6 and week 10 after first drug administration
Secondary	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	at week 2, week 4, week 6 and week 10 after first drug administration