Phase III clinical study of TY-0201 in patients with chronic atrial fibrillation -Confirmatory Study

Phase 3

Completed

• Conditions: Chronic atrial fibrillation

• Registration Number: JPRN-jRCT2080222737
• Lead Sponsor: TOA EIYO LTD.

Brief Summary

TY-0201 was confirmed to be non-inferior to the BO for reducing the heart rate in Japanese patients with persistent or permanent atrial fibrillation. Furthermore, the treatments were considered to be tolerable from a safety point of view.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Study Completion: 2016-04-28
• Results First Posted: 2018-12-24
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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, or aortic or mitral valve stenosis or regurgitation at a moderate level or higher.
(2) Patients with a history of a cerebrovascular event (except an asymptomatic cerebrovascular event).
(3) Systolic blood pressure < 110 mmHg.
(4) Patients with a disease for which anticoagulant therapy is contraindicated.
(5) Patients with poor skin condition at the patch application site or history of dermatitis caused by a topical agent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>The change of mean heart rate as determined by 24 hours holter electrocardiogram.

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>(1) Diurnal variation in heart rate as determined by 24 hours holter electrocardiogram.<br> Resting heart rate<br> Achievement rate to the target heart rate level.<br>(2) Adverse events and adverse drug reactions.