UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012816 |
|---|---|
| Receipt number | R000014974 |
| Scientific Title | The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2014/01/10 20:13:27 |
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Basic information
Public title
The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Acronym
The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Scientific Title
The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Scientific Title:Acronym
The effect of azilsartan on excercise capacity in hypertensive patients with sarcopenia
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether azilsartan is superior to amlodipine in terms of improvement in exercise capacity with functional therapy in hypertensive patients with sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Muscle strength of lower limbs
(2)Muscle mass of appendicular skeletal muscle.
(3)ABPM
(4)Serum concentration of angiotensin 1-7
Key secondary outcomes
Serum myokine concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
azilsartan
Interventions/Control_2
amlodipine
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Hypertensive patients, 65yeas of age and older
(2) The untreated hypertensive patients with BP beyond 140/90mmHg, or the uncontrolled hypertensive patients treated with single antihypertensive drugs other than RAS blockades (renin inhibitor, ACE inhibitor, ARB, aldosterone blocker)
(3) Muscle mass of appendicular skeletal muscle measured by BIA methods less than 7.0kg//m2 in male, 5.8kg/m2 in female
Key exclusion criteria
(1) The subjects found difficult to perform functional therapy because of prior stroke or orthopedic disease.
(2) The subjects who have past medical history of hypersensitivity to azilsartan or amlodipine
(3) The subjects found offensive by attending physicians for this research
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Yamamoto |
Organization
Osaka university graduate school of medicine
Division name
geriatric medicine and nephrology
Zip code
Address
2-2 Yamadaoka Suita Osaka
TEL
06-6879-3852
kyamamoto@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Yamamoto |
Organization
Osaka university graduate school of medicine
Division name
geriatric medicine and nephrology
Zip code
Address
2-2 Yamadaoka Suita Osaka
TEL
06-6879-3852
Homepage URL
kyamamoto@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric medicine and nephrology, Osaka university Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Geriatric medicine and nephrology, Osaka university Graduate school of medicine
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | 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
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2014 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014974
