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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03950843

Enrollment

162

Registered

2019-05-15

Start date

2019-04-23

Completion date

2021-12-31

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

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

Interventions

DRUGCKD-825

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

DRUGPlacebo oral capsule

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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%)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	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	2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration	To compare experimental group with placebo group
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm	at week 6 and week 10 after first drug administration	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	at week 2, week 4, week 6 and week 10 after first drug administration	To compare experimental group with placebo group

Countries

South Korea

Contacts

Primary ContactJong-ll Choi, M.D, Ph.D

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

Backup ContactJong-ll Choi