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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035403
Receipt No. 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 2019/01/04

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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
Institute Osaka university hospital
Institute
Department

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
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.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


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