UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015921 |
|---|---|
| Receipt number | R000018529 |
| Scientific Title | Effects of irbesartan and termisartan on serum levels of uric acid and endothelial function |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2018/09/28 15:21:14 |
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Basic information
Public title
Effects of irbesartan and termisartan on serum levels of uric acid and endothelial function
Acronym
Effects of irbesartan and termisartan on serum levels of uric acid and endothelial function
Scientific Title
Effects of irbesartan and termisartan on serum levels of uric acid and endothelial function
Scientific Title:Acronym
Effects of irbesartan and termisartan on serum levels of uric acid and endothelial function
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the effects of irbesartan and termisartan on serum uric acid levels and endothelial function as well as lowering effects of blood pressure
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum level uric acid
Key secondary outcomes
Changes in blood pressure and endothlial function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
irbesartan group
4 months
irbesartan 100mg/day
once every day for 4 months
Interventions/Control_2
termisartan group
4 months
termisartan 40mg/day
once every day for 4 months
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
serum levels of uric acid between 5.0 - 8.0 mg/dl and non user of ARB within 4weeks
hypertensive patients
Key exclusion criteria
serum creatinine >=1.5 mg/dl
history of gout attack
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasu Takanori |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Cardiovascular medicine
Zip code
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
tyasu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshizawa Keiko |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Cardiovascular medicine
Zip code
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
Homepage URL
kyoshi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI&CO.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018529
