UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003473 |
|---|---|
| Receipt number | R000004203 |
| Scientific Title | the study on the relationship between renin activity and hypotensive efficacy of uncombined angiotensin II receptor blockers(ARB) therapy and combined ARB+diuretic therapy for hypertension |
| Date of disclosure of the study information | 2010/04/09 |
| Last modified on | 2014/10/09 09:46:14 |
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Basic information
Public title
the study on the relationship between renin activity and hypotensive efficacy of uncombined angiotensin II receptor blockers(ARB) therapy and combined ARB+diuretic therapy for hypertension
Acronym
study of relationship between drug therapy with ARB and diuretic and renin activity
Scientific Title
the study on the relationship between renin activity and hypotensive efficacy of uncombined angiotensin II receptor blockers(ARB) therapy and combined ARB+diuretic therapy for hypertension
Scientific Title:Acronym
study of relationship between drug therapy with ARB and diuretic and renin activity
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine whether or not the use of a diuretic agent in combination with ARB can induce further elevation of renin activity compared to ARB only, and the relationship between renin activity and hypotensive effect
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hypotensive effect
renin activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
telmisartan 40mg, 7days
>telmisartan 40mg+hydrochlorothiazide 12.5mg, 7days
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. individuals with systolic blood pressure >=130mmHg and <180mmHg and/or diastolic blood pressure >=85mmHg and <110mmHg.
2. individuals who have not been received hypotensors except for Ca antagonists.
3. BMI: >=18kg/m2, <30kg/m2
4. individuals capable of understanding the study protocol and complying with the related instructions.
Key exclusion criteria
1. secondary hypertension
2. individuals with serious complications
3. pregnant and lactating women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Ohashi |
Organization
Oita University Faculty of Medicine
Division name
Dept of clinical pharmacology and therapeutics
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
097-586-5952
rinyaku@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita university Faculty of medicine
Division name
Dept of clinical pharmacology and therapeutics
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, OIta, JAPAN
TEL
097-586-5952
Homepage URL
imaih@oita-u.ac.jp
Sponsor or person
Institute
J-CLIPNET
Institute
Department
Personal name
Funding Source
Organization
research grant from government
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 04 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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 | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004203
