臨床研究等提出・公開システム

Date of registration	Aug. 29, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222593

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

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	TOA EIYO LTD.
	Address	ct_info@toaeiyo.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	TOA EIYO LTD.
	Address	ct_info@toaeiyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		40
Study Type		Interventional
Study Design	Study Design	Multicenter, Open-label study
Study Design	Objective
Phase		2
Key inclusion & exclusion 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	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.
	Minimum Age	20age old over
	Maximum Age	80age old under
	Gender	Both
Health Condition or Problem Studied		Chronic heart failure
Intervention(s)		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
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The change in LVEF
Secondary Outcome		1) NYHA functional class 2) Evaluation using the QOL questionnaire 3) Cardiovascular events

Primary Sponsor	TOA EIYO LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142644
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Feb. 19, 2016	Detail	Changes
5	Feb. 19, 2016	Detail	Changes
4	Sept. 25, 2015	Detail	Changes
3	Sept. 25, 2015	Detail	Changes
2	Aug. 29, 2014	Detail	Changes
1	Aug. 29, 2014	Detail

List of change history