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

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: CKD-825; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03950843

125AF18022

Details and patient eligibility

About

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

Full 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

Enrollment: 162 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

* 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.

Treatment:

Drug: Placebo oral capsule

Drug: CKD-825

Placebo Group

Placebo Comparator group

Description:

* 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

Treatment:

Drug: Placebo oral capsule