UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001661 |
|---|---|
| Receipt number | R000002005 |
| Scientific Title | Hypertesive Patient in Hokuriku area research of Candesartan |
| Date of disclosure of the study information | 2009/01/28 |
| Last modified on | 2010/07/27 09:55:33 |
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Basic information
Public title
Hypertesive Patient in Hokuriku area research of Candesartan
Acronym
HAKUSAN
Scientific Title
Hypertesive Patient in Hokuriku area research of Candesartan
Scientific Title:Acronym
HAKUSAN
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of Candesartan on BP and HR of hypertensive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
decreament of heart rate
Key secondary outcomes
decreament of BNP
achievement of targeted BP
variation of serum K and Cr
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
candesartan
Interventions/Control_2
other ACE-I and/or ARB
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) outpatient whose resting BP is not achieved 135/80
(2)whose hypertension is treatment naive or treated by ACE-I and/or ARB
(3)who is eligible for written consent
Key exclusion criteria
whose hypertension is treated by other agents rather than ACE-I and/or ARB
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kondo Kunio |
Organization
Ishikawa Medical Association
Division name
Ishikawa Internal Medicine Association
Zip code
Address
Kuratsuki-higashi 2-48, Kanazawa
TEL
076-239-3800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ishikawa Internal Medicine Association
Division name
Ishikawa Internal Medicine Association
Zip code
Address
TEL
Homepage URL
inano-heart@bpost.plala.or.jp
Sponsor or person
Institute
Ishikawa Internal Medicine Association
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
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
| 2009 | Year | 01 | Month | 28 | 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
| 2008 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 27 | Day |
Last modified on
| 2010 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002005
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
