UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000622 |
|---|---|
| Receipt number | R000000754 |
| Scientific Title | Heart Failure management by COmbination of STatin and ARB |
| Date of disclosure of the study information | 2007/03/01 |
| Last modified on | 2008/04/02 23:23:23 |
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Basic information
Public title
Heart Failure management by COmbination of STatin and ARB
Acronym
HF-COSTAR
Scientific Title
Heart Failure management by COmbination of STatin and ARB
Scientific Title:Acronym
HF-COSTAR
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed whether the use of a combination therapy of the ARB (losartan, LOS) and statin (simvastatin, SIM) causes the beneficial effect on chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hositalization and death caused by heart failure
Left ventricular ejection fraction (measured by echocardiography)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB group
Interventions/Control_2
ARB+STATIN group
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
The patients of chronic heart failure
Key exclusion criteria
The patient who is improper of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Isobe |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
Address
yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
BANYU Pharmaceuticals Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine, Akita University
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 03 | 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
Completed
Date of protocol fixation
| 2003 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 28 | Day |
Last modified on
| 2008 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000754
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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