Phase II clinical study of TY-0201 in patients with chronic heart failure

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222593

Enrollment

Registered

2014-08-29

Start date

2014-08-29

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 heart failure

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 heart failure due to ischemic heart disease, dilated cardiomyopathy or dilated phase of hypertrophic cardiomyopathy. 2) New York Heart Association (NYHA) class I, II or III. 3) Patients diagnosed with chronic heart failure and confirmed =< 40 % of left ventricular ejection fraction (LVEF) before the day of informed consent. 4) Patients whose medication for chronic heart failure has been optimized without any change of the dosage and administration. 5) Outpatients

Exclusion criteria

Exclusion criteria: 1) Patients without the implantation of pacemaker and whose pulse rate are < 50 beats/min. 2) Systolic blood pressure < 90 mmHg. 3) Patients with complication of hypertrophic obstructive cardiomyopathy, cardiogenic shock, severe valve stenosis or valve regurgitation, severe or multiple arrhythmia, or secondary cardiomyopathy with rapid deterioration. 4) Patients with poor skin condition at the patch application site or history of dermatitis due to a topical agent, etc.

Design outcomes

Primary

Measure	Time frame
The change in LVEF	—

Secondary

Measure	Time frame
1) NYHA functional class 2) Evaluation using the QOL questionnaire 3) Cardiovascular events	—

Outcome results

None listed

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