UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035403
Receipt number R000040339
Scientific Title Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.
Date of disclosure of the study information 2018/12/29
Last modified on 2020/03/09 13:17:17

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Basic information

Public title

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Acronym

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Scientific Title

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Scientific Title:Acronym

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Region

Japan


Condition

Condition

Idiopathic triglyceride deposit cardiomyovasculopathy (TGCV).

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A placebo controlled double-blind, repeated dose study

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Change in 6-minute walking distance (m) 8 weeks after administration.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CNT-01(500mg), Oral, 3/day, 8weeks

Interventions/Control_2

Placebo (control), Oral, 3/day, 8weeks

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have definite diagnosis of idiopathic TGCV.
2) BMIPP washout rate is less than 5%
3) Patients who walk for 6 minutes walking distance less than 400 m
4) Patients who got adequate explanation and understanding to participate in this trial and document consent by the individual
5) Patients whose age is over 20 years at the time of consent acquisition
6) Patients who can be taken orally

Key exclusion criteria

1) Patients within 1 month of revascularization of coronary arteries
2) Patients with fasting serum capric acid concentration> 10 umol / L
3) Patients who had diet therapy containing medium chain fatty acid even once in the past
4) Patients with diabetic ketoacidosis
5) A pregnant patient, a pregnant woman or a lactating patient
6) Class IV patients with NYHA cardiac function classification
7) Patients with acute coronary syndrome
8) Patients with a history of drug addiction
9) Patients who are allergic to the ingredients of the CNT-01
10) Patients who are allergic to BMIPP or iodine
11) Patients with a history of clinically important drug allergic symptoms
12) Patients with severe liver dysfunction (Child-Pugh classifications B or C)
13) Patients who took part in other clinical trial studies within 3 months
14) Patients judged unsuitable for inclusion in this clinical trial

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken-ichi Hirano

Organization

Osaka University Hospital

Division name

Cardiovascular medicine

Zip code


Address

2-15 yamadaoka, Suita, Osaka, 565-0871, JAPAN

TEL

06-6879-5111

Email

khirano@cnt-osaka.com


Public contact

Name of contact person

1st name
Middle name
Last name Daisaku Nakatani

Organization

Osaka University Hospital

Division name

Medical innovation

Zip code


Address

2-2 yamadaoka, Suita, Osaka, 565-0871, JAPAN

TEL

06-6210-8289

Homepage URL


Email

nakatani@cardiology.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka university hospital

Institute

Department

Personal name



Funding Source

Organization

Japan agency for medical research and development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Aichi medical university hosiptal
Juntendo university hospital
Chiba university hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪大学医学部附属病院(大阪府)
愛知医科大学病院(愛知県)
順天堂大学医学部附属順天堂医院(東京都)
千葉大学医学部附属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 10 Month 26 Day

Date of IRB


Anticipated trial start date

2018 Year 12 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 29 Day

Last modified on

2020 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040339


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name