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 UMIN000005066
Receipt No. R000006016
Scientific Title Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy
Date of disclosure of the study information 2011/04/01
Last modified on 2016/02/10

* 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 Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy
Acronym Impact of ARB on adriamycin-induced cardiomyopathy
Scientific Title Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy
Scientific Title:Acronym Impact of ARB on adriamycin-induced cardiomyopathy
Region
Japan

Condition
Condition Marignancy patients who will treat with adriamycin
Classification by specialty
Cardiology Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of ARB on cardiac nfunction of malignancy patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic and diastolic function by means of echocardiography
Key secondary outcomes Regional left ventricular myocrdial function by menas of speckle-trakicng method.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 angiotensin II receptor antagonist(olmesartan)
Interventions/Control_2 no medication (olmesartan)
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 Malignancy patients who will treat with adrimycin
Key exclusion criteria 1. Patients with obstructive hypetorophic cardiomyopathy 2. Allergy of ARB 3. Patients with pregnancy or likelihood of pregnancy 4. Patients with bilateralrenal artery stenosis 5. Patients receiving ARB
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address
TEL 078-382-5846
Homepage URL
Email

Sponsor
Institute Division of Cardiovascular Medicine, Department of Internal Medicine,
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiovascular Medicine, Department of Internal Medicine,
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2011 Year 04 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
2011 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2011 Year 02 Month 10 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006016

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.