UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012942
Receipt No. R000015119
Scientific Title Open Label Phase I Trial of intramyocardial AMG0001-01 administration in chronic heart failure patients with ischemic cardiomyopathy
Date of disclosure of the study information 2014/07/01
Last modified on 2016/07/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Open Label Phase I Trial of
intramyocardial AMG0001-01
administration in chronic heart
failure patients with
ischemic cardiomyopathy
Acronym Clinical Trial of intramyocardial
AMG0001-01 administration in
chronic heart failure patients
Scientific Title Open Label Phase I Trial of
intramyocardial AMG0001-01
administration in chronic heart
failure patients with
ischemic cardiomyopathy
Scientific Title:Acronym Clinical Trial of intramyocardial
AMG0001-01 administration in
chronic heart failure patients
Region
Japan

Condition
Condition chronic heart failure
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and tolerability
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of adverse event
incidence for adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 10-spot administration of 0.4mg/0.2mL/site
Interventions/Control_2
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
85 years-old >
Gender Male and Female
Key inclusion criteria ischemic cardiomyopathy
NYHA functional Class iii or iv
LVEF<=40%
Key exclusion criteria patient implanted with an LVAD
thickness of left ventricular wall<5mm
severe pulmonary hypertension
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki sawa
Organization osaka university hospital
Division name Cardiovascular surgery
Zip code
Address 2-15 Yamadaoka Suita,Osaka
TEL 06-6879-3154
Email sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru miyagawa
Organization osaka university hospital
Division name Cardiovascular surgery
Zip code
Address 2-15 Yamadaoka Suita,Osaka
TEL 06-6879-3154
Homepage URL
Email miyagawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute osaka university hospital
Institute
Department

Funding Source
Organization AnGes MG
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 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 Terminated
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 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
2014 Year 01 Month 24 Day
Last modified on
2016 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.