UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003502 |
|---|---|
| Receipt number | R000004241 |
| Scientific Title | A study on relationship between characteristics of angiotensin II blockade and pleiotropic effects of angiotensin II AT1 receptor antagonists |
| Date of disclosure of the study information | 2010/04/17 |
| Last modified on | 2011/08/11 18:22:34 |
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Basic information
Public title
A study on relationship between characteristics of angiotensin II blockade and pleiotropic effects of angiotensin II AT1 receptor antagonists
Acronym
Characteristics of angiotensin II blockade and pleiotropic effects of ARB
Scientific Title
A study on relationship between characteristics of angiotensin II blockade and pleiotropic effects of angiotensin II AT1 receptor antagonists
Scientific Title:Acronym
Characteristics of angiotensin II blockade and pleiotropic effects of ARB
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether differences in the characteristics of angiotensin II blockade affect various pleiotropic effects of ARB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Associations between the characteristics of angiotensin II blockade and changes in the markers of pleiotropic effects
Key secondary outcomes
pressure-lowering effect
pharmacokinetics
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
irbesartan 100mg/day 7days
irbesartan 200mg/day 20days
a 4-week washout period
candesartan 8mg/day 7days
candesartan 12mg/day 20days
a 4-week washout period
valsartan 80mg/day 7days
valsartan 160mg/day 20days
Interventions/Control_2
valsartan 80mg/day 7days
valsartan 160mg/day 20days
a 4-week washout period
irbesartan 100mg/day 7days
irbesartan 200mg/day 20days
a 4-week washout period
candesartan 8mg/day 7days
candesartan 12mg/day 20days
Interventions/Control_3
candesartan 8mg/day 7days
candesartan 12mg/day 20days
a 4-week washout period
valsartan 80mg/day 7days
valsartan 160mg/day 20days
a 4-week washout period
irbesartan 100mg/day 7days
irbesartan 200mg/day 20days
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with untreated hypertenstion
OR
Inadequately-controlled hypertensive patients treated with a Ca channel blocker for over 3 months
Patients without any inadequately-controlled disease other than hypertension
Patients who can give their written consent
Key exclusion criteria
Patients who have diabetes, chronic kidney disease, cardiovascular disease, or 3 or more following risk factors: current smoking, inadequately-controlled dyslipidemia, obesity, metabolic syndrome, and early family history of cardiovascular disease.
Patients treated with any antihypertensive medication other than Ca channel blocker
Patients with moderate or severe liver injury
Patients with anemia
Patients who are or might become pregnant
Patients treated with a medication which is known to affect CYP2C9 activity or glucuronyl transferase activiry
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi ANDO |
Organization
Jichi Medical University
Division name
Clinical Pharmacology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Japan 329-0498
TEL
0285-58-7388
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University
Division name
Division of Gakuji
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Japan 329-0498
TEL
Homepage URL
Sponsor or person
Institute
Division of Clinical Pharmacology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
自治医科大学附属病院（栃木県）
真岡病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 17 | 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
| 2010 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 17 | Day |
Last modified on
| 2011 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004241
