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J-BAF study Evaluation of the efficacy and safety of Bepridil hydrochloride in the conversion of persistent atrial fibrillation.A placebo-controlled, randomized, double-blind study.

J-BAF study Evaluation of the efficacy and safety of Bepridil hydrochloride in the conversion of persistent atrial fibrillation.A placebo-controlled, randomized, double-blind study. - JBEP-DBT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1091220005
Enrollment
20
Registered
2006-02-15
Start date
2006-02-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Persistent atrial fibrillation

Interventions

Intervention type:DRUG Name of intervention:Bepridil hydrochloride Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing freq

Sponsors

Bepridil central office
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Persistent AF lasting 7 days or longer by electrocardiogram in term of the surveillance

Exclusion criteria

Exclusion criteria: 1)Persistent AF lasting 1 year or longer. 2)Cardiac surgery, myocardial infarction within 1 month of the onset or unstable clinical manifestation. 3)AF because of underlying disease or complications as follows; sick sinus syndrome, giant left atrium, AF with disturbances of conduction, hyperthyrea, mitral stenosis. 4)left ventricular ejection fraction <= 40%, or heart failure level III orIV at New York Heart Association classification of cardiac performance. 5)Bradyasystolic AF. 6)marked QT increased. 7)a history of syncope because of polymorphic ventricular tachycardia or antiarrhythmic agent. 8)very low blood pressure 9)Contraindication for anticoagulation therapy 10)Severe liver and/or kidney dysfunction 11)a history of Bepridil 12)a history of administrated other CTM 13)females of known or suspected pregnancy 14)Patients disqualified participating this trial by Dr.

Design outcomes

Primary

MeasureTime frame
Rate of patients recognized sinus rhythm by electrocardiographic representation throughout clinical study

Secondary

MeasureTime frame
Time to sinus rhythm, improvement rate of subjective symptom

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026