臨床研究等提出・公開システム

Date of registration	Aug. 08, 2019
Last modified on	Jan. 26, 2024
Trial ID	jRCT2080224827

Scientific Title	Phase II clinical study of TY-0305 in symptomatic patients with hypertrophic obstructive cardiomyopathy -A pilot study-
Public Title	Phase II clinical study of TY-0305 in symptomatic patients with hypertrophic obstructive cardiomyopathy -A pilot study-

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	TOA EIYO LTD.
	Address	2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA
	Phone Number	+81-48-647-7975
	E-mail Address	ct_info@toaeiyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	TOA EIYO LTD.
	Address	2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA
	Phone Number	+81-48-647-7975
	E-mail Address	ct_info@toaeiyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Sept. 18, 2019
Target Sample Size		10
Study Type		Interventional
Study Design	Study Design	Multicenter, single-arm, open-label study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients with New York Heart Association (NHYA) functional class II or III. (2) Patients able to perform the cardiopulmonary exercise test.
	Exclusion Criteria	(1) Patients with past or current medical history of persistent ventricular tachycardia or ventricular fibrillation. (2) Patients with persistent or permanent atrial fibrillation. (3) Patients with past or current medical history of coronary artery disease.
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Symptomatic hypertrophic obstructive cardiomyopathy
Intervention(s)		investigational material(s) Generic name etc : TY-0305 INN of investigational material : Cibenzoline Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : Two tablets orally of TY-0305 50mg twice or three times daily control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Peak oxygen uptake
Secondary Outcome		efficacy safety (1) Left ventricular outflow tract gradient (2) NYHA functional class

Primary Sponsor	TOA EIYO LTD.
Secondary Sponsor	-

Name of Funding Organization
Name of Research Funding	-

Name of IRB	Japan Research Promotion Society For Cardiovascular Diseases Sakakibara Heart Institute IRB
Address of IRB	3-16-1 Asahi-cho, Fuchu-shi, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 19, 2019

Secondary ID No.	JapicCTI-194910
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Jan. 26, 2024	(this page)	Changes
6	April. 14, 2022	Detail	Changes
5	May. 11, 2021	Detail	Changes
4	Aug. 26, 2020	Detail	Changes
3	Mar. 31, 2020	Detail	Changes
2	Sept. 30, 2019	Detail	Changes
1	Aug. 09, 2019	Detail

List of change history