臨床研究等提出・公開システム

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

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

137

Patients with chronic atrial fibrillation

Consent was obtained from 165 subjects, 137 of whom were administered the study drug, 115 of whom completed the study.

Adverse events were observed in 82.5% of patients and treatment-related adverse events were observed in 23.4% of patients. Most of these adverse events were either mild or moderate.

Adverse events were observed in 82.5% of patients and treatment-related adverse events were observed in 23.4% of patients. Most of these adverse events were either mild or moderate.

The resting heart rate at baseline and at final evaluation at end of treatment was 94.7bpm and 77.6 bpm, respectively. The observed change of -17.0 bpm represents a significant decrease in heart rate (p<0.001). The percentage of patients who reached the target heart rate was 61.2%.

TY-0201 2 mg, 4 mg or 8 mg as monotherapy and TY-0201 8 mg in combination with verapamil and digoxin were all well tolerated and its rate control effect in patients with atrial fibrillation during a treatment period of 52 weeks was confirmed.

Dec. 28, 2018

No

TOA EIYO LTD.

ct_info@toaeiyo.co.jp

TOA EIYO LTD.

ct_info@toaeiyo.co.jp

completed

Nov. 20, 2014

Interventional

Multicenter, open-label study

treatment purpose

3

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

(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.

Both

Chronic atrial fibrillation

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

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
Adverse events and adverse drug reactions

efficacy
Resting heart rate
Achievement rate to the target resting heart rate level.

Oct. 23, 2014