NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051220160

Registered date:30/01/2023

An Expanded Access Program of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIdiopathic triglyceride deposit cardiomyovasculopathy
Date of first enrollment06/02/2023
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)CNT-01 is administered orally three times daily (in the morning, at noon, and in the evening). The starting dose of CNT-01 is 500 mg (1,500 mg/day) for the first 2 weeks, then the dose is increased to 1000 mg (3,000 mg/day).

Outcome(s)

Primary OutcomeAdverse event, Adverse drug reaction
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who completed the 52 weeks of administration in the CNT-01-811 study. Patients who voluntarily signed and dated the informed consent form.
Exclude criteriaPatients with diabetic ketoacidosis. Patients allergic to the ingredients of the investigational product.

Related Information

Contact

Public contact
Name Clinical Development Dept.
Address 2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA Saitama Japan 330-0834
Telephone +81-48-647-7975
E-mail ct_info@toaeiyo.co.jp
Affiliation TOA EIYO LTD.
Scientific contact
Name Yasuhiko Akita
Address 2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA Saitama Japan 330-0834
Telephone +81-48-647-7975
E-mail ct_info@toaeiyo.co.jp
Affiliation TOA EIYO LTD.