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
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
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
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
