UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038809 |
|---|---|
| Receipt number | R000042664 |
| Scientific Title | Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2022/11/29 06:56:43 |
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Basic information
Public title
Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery
Acronym
Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery
Scientific Title
Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery
Scientific Title:Acronym
Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery
Region
| Japan |
Condition
Condition
Ischemic Cardiomyopathy
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of following points of ADR-002K for patients with ischemic cardiomyopathy undergoing coronary artery bypass surgery
1)Safety
2)Efficacy (exploratory)
3)Feasibility
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1) Adverse event and safety evaluation related to this product
2) Efficacy(exploratory)
3) Feasibility
Key secondary outcomes
1) Cardiac function
2) Exercise tolerance
3) Other
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Bypass surgery and test product administration
Interventions/Control_2
Bypass surgery and placebo administration
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2) Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3) Others
Key exclusion criteria
1) Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2) Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3) Others
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | SAWA |
Organization
Osaka University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
565-0871
Address
2-15, Yamadaoka, Suita city
TEL
06-6879-3154
sawa-p@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | MORI |
Organization
Osaka University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
565-0871
Address
2-15, Yamadaoka, Suita city
TEL
06-6879-3154
Homepage URL
d-mori@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka University Hospital
Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2, Yamadaoka, Suita city
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The first case has been incorporated.
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042664
