Phase III clinical study of TY-0201 in patients with chronic atrial fibrillation -long-term study-

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222649

Enrollment

100

Registered

2014-11-11

Start date

2014-11-20

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

Chronic atrial fibrillation

Interventions

investigational material(s) Generic name etc : TY-0201 INN of investigational material : Bisoprolol Therapeutic category code : 212 Antiarrhythmic agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with chronic (persistent or permanent) atrial fibrillation. (2) Resting heart rate: >=80 bpm (3) Outpatients

Exclusion criteria

Exclusion criteria: (1) Patients with any of the following findings related to heart disease. 1) Acute coronary syndrome, coronary revascularization or variant angina within 6 months prior to informed consent. 2) Cardioversion or catheter ablation within 3 months prior to informed consent. 3) Heart rate control with a pacemaker, etc. 4) Severe arrhythmia, cardiogenic shock, heart failure, cardiomyopathy, myocarditis or reduced cardiac function, aortic valve or mitral valve with moderate or severe valve stenosis or valve regurgitation. (2) Patients with a history of a cerebrovascular event (except for asymptomatic cerebrovascular events). (3) Systolic blood pressure < 110 mmHg. (4) Patients contraindicated for anticoagulation therapy. (5) Patients with poor skin condition at the site of patch application or a history of clinically significant dermatitis caused by a topical agent, etc.

Design outcomes

Primary

Measure	Time frame
safety Adverse events and adverse drug reactions	—

Secondary

Measure	Time frame
efficacy Resting heart rate Achievement rate to the target resting heart rate level.	—

Countries

Japan

Outcome results

None listed

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