UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003518 |
|---|---|
| Receipt number | R000004270 |
| Scientific Title | Influence of Valsartan or Olmesartan on renin-angiotensin-aldosterone system and cardiac muscle |
| Date of disclosure of the study information | 2010/04/22 |
| Last modified on | 2010/06/06 03:17:27 |
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Basic information
Public title
Influence of Valsartan or Olmesartan on renin-angiotensin-aldosterone system and cardiac muscle
Acronym
Influence of Valsartan or Olmesartan on renin-angiotensin-aldosterone system and cardiac muscle
Scientific Title
Influence of Valsartan or Olmesartan on renin-angiotensin-aldosterone system and cardiac muscle
Scientific Title:Acronym
Influence of Valsartan or Olmesartan on renin-angiotensin-aldosterone system and cardiac muscle
Region
| Japan |
Condition
Condition
Hypertension after cardiac surgery
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reserch the effects of administration of Candesartan or Olmesartan in influence for renin-angiotensin-aldosterone system and cardiac muscle .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renin, angiotensin, aldosterone
UCG (LVMI, EF, LVDd, LVDs)
Key secondary outcomes
BNP
Blood pressure, heart rate
Cr, eGFR
ABI, PWV
Side effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from Candesartan to Olmesartan
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who is taking Candesarta for hypertension
Patients from whom informed consent was obtained
Key exclusion criteria
Patients from whom informed consent was not obtained
arteriosclerotic obliterans
left ventricular dysfunction(EF<40%)
patients with aldsterone escape phenomenon
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nihon University school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sekino 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
日本大学板橋病院（東京），関野病院（東京）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 22 | 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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2010 | Year | 04 | Month | 22 | Day |
Last modified on
| 2010 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004270
